What are the requirements for your specific business? Will the system be compatible with your existing hardware and software? How user friendly is the interface? These are just a few of the questions you'll need to answer before making a decision to switch to an electronic batch recording system


What are the requirements for your specific business? Will the system be compatible with your existing hardware and software? How user friendly is the interface? These are just a few of the questions you'll need to answer before making a decision to switch to an electronic batch recording system.

Here is a list of the factors to consider before making that decision.

### Scalable to support growth

The electronic batch record system should be scalable to support growth. Making sure the chosen system is able to handle multiple users, has a user-friendly interface, and can generate reports quickly and easily. And if expanding into new markets, making sure the system is able to accommodate different languages and currencies is important.

### Configurable to support changing business needs

As the business grows and changes, the batch record system must grow and change. That's why it's important to choose a system that's configurable—so it can be adapted to specific needs.

The system should be able to capture all the data, from production through shipping. Most importantly, it should be reliable with reliable batch records.

### Real-time data capture and analysis

Capturing data in real-time is vital to be able to track the progress of the batches and make sure that they're staying on schedule.

A system that provides analysis and reporting functionality is useful to be able to identify any potential problems early on and fix them before they become a bigger issue.

### Track and trace capabilities

When it comes to finding the right electronic batch record system for the business, track and trace capabilities should be near the top of the list. Being able to quickly and easily track product batches is essential for quality control and safeguarding against any potential product recalls.

This also means tracking where each batch came from, who made it, what ingredients were used, and how it was processed. This information is essential for ensuring compliance with all relevant safety regulations.

### Top tips

When looking for a quality electronic batch record system, there are a few key factors to keep in mind. Here are five of the most important:

1. **Usability**: The system should be easy to use and navigate, so batch data can quickly and easily tracked.
2. **Flexibility**: The system should be able to grow with the business, easily integrating new features and accommodating changes.
3. **Accuracy**: The system should be extremely accurate, ensuring that all data is properly logged and tracked.
4. **Security**: The system must be secure, protecting data from unauthorised access or alteration.
5. **Compatibility**: The system should be compatible with existing software and hardware.

Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


Food & Beverage

Pharmaceutical

What to look for in an electronic batch record system?

CAPA is a corrective and preventive action plan that's implemented in a manufacturing process to ensure the quality of the products being produced


CAPA is a corrective and preventive action plan that's implemented in a manufacturing process to ensure the quality of the products being produced.

But having a CAPA plan is just one part of the equation - having a system in place to track and record these corrective and preventive actions is vital. This is where electronic batch recording comes in.

### What is CAPA?

CAPA is short for corrective and preventive action. It's a process that helps identify and address problems before they become big issues. And it's a critical part of any manufacturing process.

But implementing a CAPA plan can be difficult, especially without the right tools. That's where an electronic batch recording system comes in. It can help track batches of product as they move through the process, so problems are quickly identified.

### How can an electronic batch recording system help CAPA planning?

The EBR system can help automate the CAPA process, making it easier and faster to identify and track any potential problems.

An electronic batch recording system can also help generate reports that document the history of each batch of product. This information can be vital in proving that the CAPA plan is effective and helping avoid any costly penalties from regulatory agencies.

### Are there any other benefits of EBR Systems?

An electronic batch recording system can be an important piece of a CAPA plan. But some other benefits of an EBR system are:

- Real-time updates on the manufacturing process, so less time spent on investigating issues and more time fixing them.
- All data will be in one place, running reports is quicker and easier, without having to spend hours compiling information from different sources.

When it comes to ensuring the quality of products, having a corrective and preventive action (CAPA) plan is essential. An electronic batch recording system can help track the history of every product, from production through delivery. This information can be used to evaluate and improve a CAPA plan. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


CDMO

How an electronic batch recording system helps with CAPA planning

When it comes to discrete event simulation (DES), electronic batch recording software can play a big role in recreating a factory in the virtual world


When it comes to discrete event simulation (DES), electronic batch recording software can play a big role in recreating a factory in the virtual world. This type of software is versatile and has various applications, such as scheduling, capacity planning, resource allocation, bottleneck identification, and scenario analysis.

### What is a DES model?

A DES model is a factory in the virtual world. It recreates a sequence of events occurring at discrete time points. Essentially, it helps with planning and characterisation of processes.

But how to use a DES model to improve manufacturing processes? By using an electronic batch recording software. This software can help with data collection, which is essential for building a DES model.

With the right data, manufacturers can optimise their production line and make sure that everything is running as smoothly as possible.

### What are the benefits of using a DES model?

First and foremost, a DES model can help optimise production processes. It can also help identify and fix any bottlenecks in the system. Additionally, with a DES model manufacturers can run different scenarios to see how they would play out—this is a great way to test out different options and make decisions based on data rather than intuition.

Ultimately, using a DES model will help make better, more informed decisions.

### How can an EBR software help with DES models?

An electronic batch recording software can help with DES models by tracking the batches of materials that come into and go out of the factory. This information can then be used to create a more accurate simulation of the factory.

By recording the time, date, and quantity of each batch, the software can help identify any bottlenecks in the production process. It can also help with resource allocation and scheduling, so that the factory can run as efficiently as possible. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


How an electronic batch recording software can help with DES models

When it comes to manufacturing processes, it's important to collect data in order to track performance and ensure quality and efficiency

When it comes to manufacturing processes, it's important to collect data in order to track performance and ensure quality and efficiency. 

When it comes to judging the quality and efficiency of manufacturing processes, key performance indicators (KPIs) are used to quantify performance.

But what KPIs should manufacturers use? And how is the data needed collected?

Some of the most important KPIs for judging process performance:

* Yield (or yield percentage)
* Productivity
* Cost per unit
* Scrap rate
* Cycle time

### KPIs to use to judge quality and efficiency

KPIs are measurements that help gauge the success of manufacturing processes, and operations. There are a lot of different KPIs, but here are a few that are particularly important:

* Percentage of defective products
* Percentage of products that meet customer specifications
* Manufacturing cycle time
* Percentage of rejects

### Why these KPIs are important

KPI stands for key performance indicators, which are a set of metrics used to measure the success of a particular process. When it comes to manufacturing processes, there are a few KPIs that are particularly important.

The first is yield, which is a measure of how much product is actually produced as compared to the amount that was intended. This is an important metric because it tells how efficient the process is.

The second KPI is quality rate, which is a measure of the number of defective products that are produced as compared to the total number of products. This tells how well the process is functioning and whether or not it's meeting customer demands.

The third KPI is throughput, which measures the amount of product that is moving through the process. This gives an idea of how efficiently the process is running and how much work it's able to handle.

Collecting data in electronic batch records can help track these KPIs and make sure the manufacturing processes are running as smoothly as possible.

### How to implement these KPIs

Data collected in electronic batch records can be used for quantifying process performance. This data can be used to track key performance indicators (KPIs) such as yield, quality and efficiency. By monitoring these KPIs, judging the quality and efficiency of manufacturing processes and making necessary changes to improve them is easier. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

KPIs to use when judging quality and efficiency of manufacturing processes

Creating an EBR in a brewery is a valuable way to improve efficiency and accuracy in the manufacturing process

Creating an EBR in a brewery is a valuable way to improve efficiency and accuracy in the manufacturing process. By tracking all the data related to the production of a product, an EBR can help breweries keep track of and control their manufacturing processes. This information can be used to optimise production processes and make better decisions about resource allocation. Additionally, it can help identify problems early on and fix them before they become serious issues.

Breweries use an electronic batch recorder (EBR) to track all the data related to the manufacturing of a product. This data includes things like recipe ingredients, volumes of each step in the manufacturing process, and other information that is useful for controlling and monitoring their manufacturing processes. By recording this data, breweries can ensure accuracy and consistency in their products, and make better decisions about how they produce them.

### How is an EBR system implemented?

There are a few different ways that an EBR can be implemented in breweries.

The most common way is to have a computerised system that records all the data related to the manufacturing of a product. This includes things like batch numbers, production times, and other information related to the production process. This information can then be used to analyse and improve processes in future batches, as well as track performance over time. 

Another popular way is to use RFID (radio frequency identification) tags on tanks and barrels. These tags will automatically record information about the contents of those tanks or barrels, including temperature, pressure, and other data related to the manufacturing process. This data can then be used for quality control purposes, as well as inventory management.

Either way, an EBR is a valuable tool that breweries can use to improve their manufacturing processes and keep track of everything that's happening during production.

An EBR is a system that tracks all the data related to the manufacturing of a product. This includes information like grain yields, water usage, fermentation data, and more. It also records how every beer was made, which allows breweries to keep track of their production processes and ensure that they're making the right beers at the right time. This information is useful not just for quality control purposes, but also for financial analysis and marketing research. By having comprehensive records of their production process, breweries can optimise their workflow and improve efficiency overall. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).


Implementation of EBRs in breweries 

The rapidly growing global population is projected to reach 9

### ***The challenge of feeding an exploding population and cellular agriculture as an opportunity to address forthcoming challenges of the food industry***

The rapidly growing global population is projected to reach 9.8 billion by 2050, which presents tremendous food challenges for the world. In 2012, the Food and Agriculture Organization of the United Nations predicted the global demand for meat to rise by 34% from 2018 levels, reaching a total of 455 million metric tons by 2050. Similarly, the global demand for fish is expected to reach 140 million metric tons by the same year. While this increase in demand is mostly attributed to middle-income countries such as China, consumption in higher-income countries such as the United Kingdom remains relatively stable or marginally declining. In response to public health, environmental, and animal welfare concerns associated with the current methods of the animal agriculture industry, consumers are looking for ways to reduce their consumption of animal origin products. Nonetheless, the rising global demand for protein food ingredients ultimately acts as a driving force for innovation in the food industry opening new opportunities for producing sustainable food and shaping our future agrifood landscape. 

The food industry is seeking opportunities to expand alternative protein sources that are both environmentally sustainable and nutritionally adequate. Meanwhile, traditional meat protein production is additionally challenged by limited global arable land and climate change. Cell-based food production or cellular agriculture, which involves growing animal products directly from cell cultures instead of using livestock, has emerged as a potentially sustainable option. With the FDA completing its first pre-market consultation for human food made using animal cell culture technology in November 2022, there are now over 100 start-ups worldwide exploring the area of cell-based food products (also referred to as cell-cultured foods and cultivated meat). This commercial landscape is rapidly expanding, with various food products such as various meats, poultry, fish, aquatic products, dairy and eggs in the roadmap for future commercialization. 

### ***Electronic batch record systems as a tool to benefit and enable innovation for cell-based food production***

In recent years, the use of electronic batch record (EBR) systems has become increasingly popular in the food industry, particularly in cell-based food production. This technology can offer various benefits to producers, beyond its main advantage - tracking and managing the product production life cycle electronically - such as reducing manual errors, improving manufacturing efficiency and increasing productivity. An electronic system can ensure that there are no exceptions or errors in a batch and because the data can be automatically recorded instead of transcribed by operators, it provides improved quality control, allowing to form better pricing mechanisms and reduce risks of product recalls. This means that every batch of food is made according to exact specifications, achieving consistency in quality. By monitoring the production process, producers can identify issues early on and take corrective action before the batch is completed, further improving the quality of the final product. Moreover, by identifying the areas of improvement in the production process, EBR systems can assist with the management of production waste, in that reducing waste would lower production costs and enhance profitability. Additionally, by automating the process of data collection and analysis, cell-based food producers can perform production releases of batches and production runs much quicker, saving time and resources. Therefore, with an automated operational system in place, manufacturers can quickly recognise the root of many problems and take appropriate measures - not only protecting consumers but also maintaining the producer's brand name. Another advantage of an EBR system is that it can help to streamline regulatory compliance. Food safety is always a top concern for food and beverage manufacturers, therefore to meet the strict regulations governing the production and distribution of food products, the manufacturers must be able to identify and trace individual ingredients utilised in the manufacturing process, from receipt through processing, packaging, and shipping to the customer. By using an EBR system, manufacturers can record and manage data related to each batch, making it easier to demonstrate compliance with these regulations. Taking into account that the complexity of regulatory compliance can ultimately stall the manufacturers’ growth, the appropriate software application can help avoid such drawbacks by providing the capability to track real-time data throughout the whole manufacturing and supply cycle during production and storing the data for future reference.

### ***Bringing technologies together*** 

In order for a revolutionary innovation like cultivated meat to reach its maximum potential in terms of both environmental sustainability and economic feasibility, a comprehensive approach that involves and motivates the entire meat industry value chain will be required. This approach will require a critical path that includes four main steps, each enabling the next: the establishment of a stable regulatory environment, cost-effective and low-carbon production on a large scale, widespread consumer acceptance, and high-volume consumption. It is unlikely that any one company will have the necessary financial or operational resources to advance cultivated meat technology to the point where it can effectively compete. Therefore, active collaboration among stakeholders in the cultivated meat value chain will likely be required. By working together, the stakeholders can achieve various objectives, such as securing farmer acceptance and protection during the transition, advocating for regulatory change, and investing in technology development.

Electronic batch record systems have already proven as an empowering technology for ensuring product quality and consistency in various industries, such as pharmaceuticals, biotechnology, and food and beverage. In the context of cell-based meat production, EBR systems can promote and support innovation within the cell-cultured meat space by streamlining the production process, improving quality control, and reducing the risk of contamination. By being able to access and manipulate real-time data on production processes, both research and development and manufacturing teams can identify areas for improvement. EBR systems can be utilised by cell-based food producers to become more efficient and cost-effective. For instance, by following production processes step by step to identify bottleneck points and inefficiencies and therefore, develop appropriate strategies for optimization these processes. Lastly, EBR systems can help with waste management. Accordingly, by utilising the full spectrum of advantages of the EBR systems, the cell-cultured food producers can facilitate the success of a company's operations. As the food industry continues to evolve, it is likely that more teams will adapt the EBR systems to meet the growing demands of consumers for high-quality, safe, and sustainable food products whilst achieving data integrity, saving time, and ensuring compliance.

### Key Takeaways

* When it comes to the development process of cell-based foods, an electronic batch record system can help with process management.
* This is because an electronic batch record system can automate tasks, track data, and provide alerts and warnings.
* Ultimately, this means that the development process of cell-based foods can be more efficient and accurate. Read about Opvia’s EBR software and sign up for a demo [here](https://www.opvia.io/contact).

What are the benefits of an electronic batch record system for cell-based foods?

An electronic batch record system can be an extremely valuable tool for cell-based food producers

An electronic batch record system can be an extremely valuable tool for cell-based food producers. By tracking the production process electronically, each batch of food is made according to your exact specifications. This can help to improve product quality, while also minimizing the risk of product recalls.

### Benefits of an electronic batch record 

An electronic batch recording system is an important tool for ensuring the quality and safety of cell-based foods. By providing an accurate, real-time record of the production process, it helps to identify any issues that may occur and prevents them from becoming a safety hazard.

Some of the benefits of using an electronic batch record system include:

* Eliminating the need for paperwork
* Reducing the risk of human error
* Preventing cross-contamination
* Ensuring the accurate tracking of ingredients and products

### Features of an electronic batch record system

When it comes to the development process of cell-based foods, an electronic batch recording system can be a huge help with process management. By automating the recording of data during the manufacturing process, all relevant information is captured and easily accessible. This can help track the quality and safety of the products, as well as identify any potential issues that need to be addressed.

In addition, electronic batch recording systems come with a range of features that can make your job a lot easier. These include:

* Automated recording of data
* Track product history and trends
* Generate reports on product performance
* Easy access to data for analysis

In addition, an electronic batch record system can help  streamline production processes. By tracking production data electronically, problems or bottlenecks can be quickly identified and solved. This can help the optimization of  production schedules whilst ensuring that the cells are processed as quickly and efficiently as possible. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).

Electronic batch records for cell-based foods data management

Electronic batch records (EBRs) are an essential part of any mammalian cell culturing process

Electronic batch records (EBRs) are an essential part of any mammalian cell culturing process. They provide a reliable and secure way to track and manage data throughout the manufacturing process. Having accurate and up-to-date EBRs can help you troubleshoot these issues quickly and minimize any potential losses.

In a bioprocess where mammalian cells are being cultured keeping track of all the data related to the cell culture process is vital. This includes data on: 

* Type of cells
* Growth conditions
* Any factors that could influence the outcome of your experiment

Keeping track of this information in an electronic batch record is easier and faster. They're like an electronic lab notebook, where all the data related to your experiment is recorded from the starting conditions to the final results. Electronic batch records make it easy to keep track of your data, and they also help with compliance monitoring and reporting. They're an essential part of any data management system.

### Benefits of electronic batch records

With EBRs, every step of the process from inoculation to harvesting is tracked.  Electronic batch records also provide a number of other benefits, such as:

* **Speed**: With electronic batch records, the progress of your product through each stage of the manufacturing process is quickly tracked. This helps to ensure that everything is running smoothly and on schedule.
* **Accuracy**: By tracking data electronically, a high level of accuracy is guaranteed. There's no need for manual entry or transcription errors.
* **Traceability**: An EBR provides a complete history of every step in the manufacturing process, so any issues are found quickly and easily.
* **Quality Control**: The electronic batch record is an essential tool for quality control. It allows for trends and pattern spotting, problem identification and troubleshooting.

### EBRs in mammalian cell culturing

In the mammalian cell culturing process, effective data management is critical. Tracking the progress of each batch, as well as any changes or deviations that occur is vital. 

An electronic batch record is a digital record of each step in the manufacturing process. This includes information such as the date and time, ingredients, and any changes or notes that were made. This is really important for ensuring the quality and consistency of your product. With EBRs, root cause analysis and making the necessary corrections is faster. This helps to ensure that the product meets high standards and that customers are satisfied.

When it comes to data management in mammalian cell cultures, electronic batch records play a crucial role. By automating the recording and tracking of data throughout the process, EBRs help ensure that all relevant information is readily available when needed. This enhances transparency and accountability, and helps protect the quality and consistency of the cells being cultured. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

How electronic batch records support data management in mammalian cell cultures?

Continuous fermentation is a great option for brewers who want to streamline their process and ensure consistent quality

Continuous fermentation is a great option for brewers who want to streamline their process and ensure consistent quality. It is a method of brewing that involves a continuous addition and discharge of the solution in the system. This system is usually operated at a lower pH to inhibit the production of acetic acid and lactic acid.

### Why is it important to manage quality in continuous fermentation?

Managing quality in continuous fermentation is important to ensure the consistency and quality of the product. Using data control through electronic batch records is a great solution. Electronic batch records (EBRs) allow manufacturers to monitor and adjust the process in real-time and keep track of all the important information about each batch of beer.

It's all about consistency, quality, and accuracy when it comes to making beer. And that's why it's so important to manage these aspects of continuous fermentation.

Continuous fermentation is a great way to improve the quality and consistency of the beer. By implementing EBRs for data control, managing the process and making sure the beer is always up to standard is done in an efficient manner. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

How to implement continuous fermentation in your brewery?

When it comes to microbial studies, having accurate and up-to-date electronic batch records is essential

When it comes to microbial studies, having accurate and up-to-date electronic batch records is essential. Electronic batch records can help track the progress of these studies, as well as ensure that important data is consistently being gathered. With accurate electronic batch records, CROs avoid losing valuable time and resources.

### What is continuous culture?

Continuous culture is a state where either the feed rate of a growth-limiting substance keeps cell density constant (a chemostat) or cell density determines the feed rate of the substrate (turbidostat). In other words, the cells are fed at a rate that keeps their population density constant. This is different from traditional batch culture, where all of the cells are grown in one large batch and then harvested.

Cell retention can offer another, very productive option (perfusion). In perfusion culture, fresh media and nutrients are constantly pumped into the system, allowing for high cell densities and long-term production. This state is good for studying microbial metabolism or long-term production.

### What are the benefits of continuous culture?

So what does all this mean for microbial studies? There are a few key benefits:

1. **Ability to study microbial metabolism in real time** : Allows manufacturers to see how the cells are reacting to different conditions and substrates in real time.
2. **Greater productivity** : Manufactures can achieve far higher cell densities than with batch culture. This means manufacturers get more product out of each run.
3. **More accurate data** : Cells can be studied in real time, so more accurate data is gathers, which in turn helps make better decisions about the process and product.

Electronic batch records offer a way to streamline microbial studies, making them more efficient and productive. They help keep track of data and make sure that manufactures get the most out of the process and product.

### How can electronic batch records help with microbial studies?

Microbial studies can be difficult and time-consuming, but with the help of electronic batch records, they can be a lot easier. With electronic batch records, keeping track of all the important information about the study, from the ingredients used to the results achieved is easier. This information is easy to access and can be customised to meet specific needs.

This is a great tool for microbial studies because it helps stay organised and makes it easy to track progress. It also allows for greater collaboration as sharing information with other researchers is simple. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo[here](https://www.opvia.io/contact).

Electronic batch records for microbial studies

The term "big data" is being thrown around a lot lately but what does it actually mean, and more importantly, what can it do for manufacturers? Put simply, big data is the collection of large data sets that can be analysed to reveal patterns and trends

The term "big data" is being thrown around a lot lately but what does it actually mean, and more importantly, what can it do for manufacturers?

Put simply, big data is the collection of large data sets that can be analysed to reveal patterns and trends. This information can be extremely valuable for making better business decisions.

In the context of manufacturing, data analytics can be used to improve efficiency in a number of ways. For example, data from electronic batch records can be used to identify process bottlenecks and improve Overall Equipment Effectiveness (OEE).

### Data analytics can be used to optimise production processes.

With access to real-time data, performance of production processes and inefficiencies can be quickly identified and fixed. This is where data analytics comes in.

By analysing data from electronic batch records, identifying trends and making better informed decisions about how to optimise production processes is easier. For example, a particular machine may consistently produce products that are below the desired quality level. With this information, corrective action can be taken to fix the problem.

In addition, data analytics can help reduce wastage and improve inventory management. By understanding how products are flowing through the manufacturing process, better decisions about what needs to be produced in-house and what can be sourced from suppliers are made.

Data analytics is a powerful tool that can help improve the efficiency of manufacturing operations.

### Data analytics can be used to identify process improvements.

When it comes to data analytics in manufacturing, one of the most important sources of data is electronic batch records. This is basically a record of every step in the manufacturing process, from the time the ingredients are added to the mixer to the time the product is shipped.

Using data analytics, examining this data to identify process improvements. For example, there may be a lot of variation in the weight of products coming out of the mixer. By identifying and correcting this issue, the manufacturing process is improved resulting in increased efficiency.

Data analytics can also be used to improve quality control. By identifying defects early in the process, preventing them is easier.

### Data analytics can be used to monitor inventory levels.

Data analytics can keep track of inventory levels. With this information, placing orders for new stock well before running out, and keeping production lines running smoothly is easier.

### Data analytics can be used to track quality control metrics.

When it comes to data analytics, one of the most important things to track is quality control metrics. This is where electronic batch records come into play.

An electronic batch record is a digital record of every step in the manufacturing process. This includes data such as the ingredients that were used, the time and date stamps, and the results of any quality control tests.

Manufacturers have been collecting data for years, but it's only been in recent years that the data has been analysed to improve the efficiency of the manufacturing process.

Data analytics can help identify inefficiencies in the manufacturing process and recommend solutions. In particular, data from electronic batch records can be helpful for data analytics.

Manufacturing is a complex process and there are many variables that can affect the outcome. Data analytics can help identify the factors that contribute to quality defects and recommend solutions. The bottom line is that data analytics can help manufacturers improve the quality and efficiency of their manufacturing processes and this is facilitated using an EBR system. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

How data analytics can improve manufacturing efficiency

When dealing with something as sensitive as bioproducts, having a system in place that ensures quality is maintained at all times is very important

When dealing with something as sensitive as bioproducts, having a system in place that ensures quality is maintained at all times is very important. An electronic batch record is a system that helps with this as it facilitates the tracking the production of bioproducts from start to finish. 
It helps keep track of all the important data associated with the process, such as:

* The date and time the batch was started
* The date and time the batch was completed
* The name of the person who started the batch
* The name of the person who completed the batch
* The type of bioproduct being produced
* Any special instructions or notes associated with the batch

### What is downstream bioprocessing?

Downstream bioprocessing is the extraction, purification, and packaging of the product resulting from fermentation. It's a critical step in the production of bioproducts, and it's essential that the quality of the product is maintained at this stage.
With the focus on quality control at this stage, an electronic batch record can help with troubleshooting due to the easy root cause analysis.

### What are the quality control measures in downstream bioprocessing?

As a bioproduct manufacturer, it's important to have a robust quality control (QC) program in place throughout downstream bioprocessing. This includes the extraction, purification, and packaging of the product.

But QC is only effective if accurate and timely data is tracked. That's where an electronic batch record comes in. It can help keep track of all the critical parameters, so making sure the product meets the necessary standards is easier.

Maintaining the quality of a bioproduct is essential to ensure its therapeutic efficacy and safety. In the downstream stage of a bioprocess, the quality of the bioproduct must be constantly monitored and controlled to ensure that it meets all the quality standards.

An electronic batch record can help in this process by recording all the critical information about the production of the bioproduct. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

Importance of an electronic batch record in downstream bioprocesses

### What is pharma 4.0?

Pharma 4.0 is a spinoff from industry 4.0 that focuses on the use of automation and technology to change medical drug development and manufacturing. It's an effort to make this process more efficient, faster, and cheaper, so that more drugs can be made available to more people in a shorter amount of time.

One of the most important aspects of pharma 4.0 is the use of big data and analytics to improve decision-making. By recording all the data related to a particular drug or set of drugs, EBRs can help identify any potential problems early on in the development process. This information can then be used to make better decisions about which drugs to pursue further and which ones to abandon altogether.

### How can an EBR help?

In addition to improving overall efficiency, EBRs can also help protect patients by ensuring that potentially harmful drugs are never released into the market. One of the most important benefits of using EBRs is that they can help speed up the process of drug development. By tracking data related to each step in the manufacturing process, it becomes much easier to identify potential problems and make adjustments early on in the process.

EBRs automate many of the processes involved in drug development and manufacturing, including tracking product batches throughout the entire manufacturing process. This helps to improve accuracy, quality and efficiency. EBRs can also help to reduce waste, since they help to identify problems early and correct them before they become big issues.

Furthermore, EBRs can play a role in automating medical device approvals. By collecting data on how products are performing during testing and use, EBRs can help ensure that devices are safe and effective before they're released to the public. They can also help to improve compliance with regulatory requirements by helping to track changes in product features over time.

Thus, EBRs are a valuable tool for pharmacists working in pharma 4.0 environments, helping them to achieve the goals of the initiative while maintaining safety and quality standards. Read about Opvia’s [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

How can an EBR help implement pharma 4.0 objectives?

Control is an important factor in process driven industries because it helps manufacturers to ensure that their products are consistent and predictable


Control is an important factor in process driven industries because it helps manufacturers to ensure that their products are consistent and predictable. This is important because it allows them to anticipate and manage any potential problems that may arise during the production process.

Process manufacturers typically work with complex recipes or formulas to develop and manufacture products. Their production process is complicated and goes through multiple stages. Each stage of the production process has its own set of specific requirements that must be met in order for the product to reach its final stage. If anything goes wrong during any of these stages, it can have serious consequences for the entire manufacturing process.

Therefore, it's essential for process manufacturers to have tight control over every step of their production process to ensure that everything runs smoothly and meets all the required standards. This way, they can avoid any unwanted delays or complications, which would ultimately lead to reduced profits.

### What is an electronic batch record? 
Electronic batch records (EBRs) are a great way to track data related to a batch production. It is a data management system that collects, tracks and stores all product data in a centralised repository. This makes data more accessible, accurate and facilitates collaboration amongst production teams.

### What are the benefits for process manufacturers? 

An electronic batch record (EBR) system is useful to process manufacturers to better track their production process. By logging each step of the production process, an EBR system can help manufacturers keep track of ingredients, manufacturing parameters, and other information related to their products.

This information can then be used to improve the quality and accuracy of their products. It can also help them identify any abnormalities or problems early on in the production process, which would ultimately save time and money. EBR systems can help manufacturers manage inventory more effectively. This is useful because it eliminates the need for expensive stock-outs and excess inventory, both of which cost businesses money. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).


Why do process manufacturers need an electronic batch record (EBR) system?

When working on a product, it's important to have a document management system in place to help track the product's lifecycle

When working on a product, it's important to have a document management system in place to help track the product's lifecycle. A product lifecycle management helps manufacturers collect and store all the necessary documents, so they can reference them later when needed.

But what are the aspects of product lifecycle management? What are the documents collected by the software? How does document management go hand-in-hand with a PLM software? 

## What is product lifecycle management?

It's a process that helps organisations manage the entire life cycle of a product, from inception to end-of-life. This includes everything from design and development to production, marketing, and eventual disposal.

## Aspects of product lifecycle management

There are a lot of different aspects to consider when it comes to product lifecycle management, and that's why it's so important to have the right software in place. The functions of a PLM include: 

 1. **Concept & design:** The phase where a PLM records all product's requirements based on data analysis of the market, competitor and customer needs. 
 2. **Development:** All designs are recorded. Prototype development and pilots are tracked and a vital component is the generation of feedback and how the product is iterated. With all design components tracked on an electronic software, making and tracking design changes (i.e. measurements, material, etc.) is easier on a PLM software. 
 3. **Production & launch:** This is where the design is finalised and production is scaled to meet market demand. Establishing an efficient manufacturing process is very important to reduce product-to-market time. An automated software also makes deviation tracking easier which ensures high quality of the product.  
 4. **Services & support:** Tracking product feedback and providing support services. 

Documents need to be collected and organised in a way that makes sense for the business, and manufacturers need to be able to track and trend data so they can make better decisions about their products.

A PLM is known to store all the documents that are associated with a product but another important aspect of the software is the role it plays with regards to facilitating communication between product stakeholders. In order to facilitate communication, document management of all the data collected is very important. 

With the manual data collection tasks automated by a PLM, time spent on document control is eliminated. This allows manufacturers to focus on more important tasks and boosts operational efficiency.

Another key aspect of PLM is communication. The software provides a central hub where team members can share information and collaborate on projects. All the data and documents are also stored in a centralised repository and this ensures that everyone is always up to date on the latest developments and can make decisions quickly and efficiently.

## Documents management within the PLM

When it comes to product lifecycle management, the software will collect a range of documents from stakeholders across the organisation. The documents a PLM records and tracks: 

 1. Bill of materials 
 2. Product designs and engineering drawings 
 3. Regulatory compliance documents 
 4. Workflows and processes 
 5. Team tasks and management
 6. Device master record (DMR)
 7. Design history files (DHF)
 8. Suppliers information and tracking 
 9. Product costs
 10. Quality and product tests

With regards to the collection and storage of all these documents, there are three steps regarding how these documents are managed. 
1. All the relevant documents associated with the product are collected. This could include anything from design drawings and specifications to test reports and change orders.
2. These documents are uploaded into the software. This makes them easily accessible to everyone on the team, which saves time and eliminates the need to search through physical files cabinets.
3. Once the documents are uploaded, manufacturers can start tracking and managing them throughout the product lifecycle. Custom workflows approval processes can be created , so everyone knows what's expected of them and when. Reports can be automatically generated to track progress and performance.

## The Benefits of Product Lifecycle Management

With a good PLM system in place, manufacturers can easily collect and manage all the important documents related to the product—including design drawings, test reports, user manuals, and more. This way, manufacturers can establish a single source of truth for all their product data.

In addition, with a good PLM system, managing the product development process is more effective. Manufacturers are able to track changes to their documents, and have a better understanding of how their products are performing in the market.

PLM can also help with compliance and regulatory requirements. Manufacturers know exactly what documentation is needed to be submitted to the authorities. Sign up for a demo [here](https://www.opvia.io/contact).


A comprehensive document management guide to PLM

The food and beverage industry is one of the economy's largest industries globally generating millions of goods each day


The food and beverage industry is one of the economy's largest industries globally generating millions of goods each day. However the perishable nature of these products means that quality control throughout the supply chain is vital to avoid costly mistakes and product recalls.

![](media/screen-shot-2022-08-19-at-5.21.55-pm.png)

### Here are some benefits of using an EBR:

1. **Traceability:** This is imperative for manufacturers that produce products that contain allergens along with allergens-free versions in the same facility. Traceability controls within an EBR system are vital to ensuring no cross contamination occurs throughout the production process. The controls include the system enforcing the correct ingredients and packaging materials that are used for a specific batch of a product.

![](media/screen-shot-2022-08-19-at-5.22.44-pm.png)

1. **Compliance:** Regulatory compliance within the food industry is very stringent and constantly changing. Keeping up to date with these changes is easily done on a software solution that is more transparent and flexible. Changing guidelines are calling for greater transparency in the manufacturing processes. For example, the Federal Trade Commission is also set to set out new guidelines this year to make sure companies are more transparent with their processes along with also having reliable evidence for their claims. This is forcing manufacturing productions to rethink their supply chains and product life cycles. These guidelines can be better enforced and communicated using a digital solution. For example, the temperatures of perishable goods must be recorded throughout the stages of manufacturing and production and this can be better recorded and managed on an EBR.
2. **Stock Management:** Efficient management of perishable stock is vital when fresh ingredients reach the production stage. Features in an EBR such as batch-tracking, predictive stock management makes this easier and more sustainable without any wastage.
3. **Analysis:** Using an EBR, all the data is stored in a synchronous format which makes it easier to organise and analyse in the future. This analysis can be useful for optimization of the product or the manufacturing process.

The digitization of this process driven industry is paving way for necessary changes to ensure quality assurance and compliance which in turn reduce costs for the company.

Opvia’s no-code EBR solution is a simple yet effective solution that can be made to fit for various manufacturing processes in the F&B industry. Following from the points discussed in this article some features included are registries, electronic signatures, and the ability to easily connect data samples. Read more about Opvia’s solution .


Benefits of using an EBR in the food and beverage industry

The global contract development manufacturing organisation (CDMO) industry is growing rapidly


The global contract development manufacturing organisation (CDMO) industry is growing rapidly. As demand rises for generic medicines alongside an increased need for intricate and expensive production processes, more and more R&D companies are looking to outsource their drug development, and manufacturing.

![](media/screen-shot-2022-08-19-at-5.45.04-pm.png)

With the growing demand, fostering communication and collaboration between CDMOs and R&D customers is increasingly important.

### Here are some best practices to ensure this is achieved. 

1. **Visibility of Process:** The supply chain in this industry is increasingly complex due to the number of people and stages involved. There is a need for greater visibility throughout a product’s life cycle. An EBR is essential here as customer audits and viewing controls features make it possible for customers to have visibility and influence over the manufacturing process.

![](media/screen-shot-2022-08-19-at-5.45.17-pm.png)

2. **Quantitative Results:** In order to evaluate the product on its quality and performance, measurable results from the manufacturing process are necessary. Efficient data analysis on an EBR can be used to evaluate the process performance.
3. **Consolidation of Data:** The quantitative metrics from the data analysis should be consolidated into reports that can be sent to customers to ensure they are satisfied with the process and the product. It is also important to use these metrics to validate the manufacturing process and technologies being used to ensure high quality and productivity within the CDMO.
4. **Review Process:** The R&D customer must review the batch records upon completion and this can be a time consuming process if they need to review an entire manual record. In contrast, with an EBR, an additional feature is the addition of completion certificates signed by authorised people which makes the review process much more efficient.

CDMOs are customer focused organisations and the implementation of an EBR helps in ensuring that there is smooth communication with the two stakeholders along with a high quality, and safe end product. The industry is highly fragmented with many players occupying market share, so following these best practices will also provide a competitive edge.

![](media/screen-shot-2022-08-19-at-5.47.23-pm.png)

Opvia’s no-code software solution is ideal for CMO/CDMOs to keep track of their manufacturing process. The simple platform also allows for greater collaboration with external sites, and stakeholders which is vital for research and process management. Read more about it .


Best Practices for a perfect EBR for CDMOs

The principles of Bioprocessing 4.0 focuses on the implementation of AI to visualise data is becoming popular with companies looking to focus on predictive analytics. 

Predictive analytics uses machine learning techniques such as digital twins, or statistical models to make predictions about future outcomes. In the bioprocessing industry, this is used in all stages of product development: 

1. **Early-stage:** Used to compare batches and understand what leads to the desired outcome. 
2. **Late-stage:** To scale-up manufacturing processes and compare process performances at various scales of production. 
3. **Production stage:** Real-time monitoring and analysis to detect faulty batches earlier and with lower costs.

![](media/screen-shot-2022-08-22-at-9.43.49-am.png)

Without a digital system to track, and organise data from bioprocesses, analytics becomes very difficult and time consuming to perform. Automated data collection systems help with processing and validating data from various instruments and workflows. In addition, these systems have data analysis capabilities such as data filtering, or sorting.

The next step for the industry is for companies to adopt digital twins of their physical systems and processes. Whilst the concept of a digital twin is not new it is only recently that they have been easier to implement due to the availability of digital data. Automated data collections systems provide the data (i.e. bioprocesses of cell growth) to the machine learning model. The algorithm then models and maps this data against multiple dimensions. 

![](media/screen-shot-2022-08-22-at-9.45.29-am.png)

Digital twins have many uses in the bioprocessing industry to optimise the bioprocess in a defined environment. For example, this process can be used in upstream processing under growth kinetics or specific metabolite consumption rates or in downstream processing under neural networks. The aim is for bioprocessing companies to effectively create a closed-loop predictive model that can ensure greater control and quality in their development processes. 

The first step to achieve this predictive model is to centralise their data throughout the life-cycle of the product to be able to have enough metadata and contextualization to be able to create these models. Having the right software for data collection is essential to be able to easily input data, collaborate between users and then organise the data. Due to the complexity of bioprocesses and their high variability, an integrated workflow that validates information and process data so batch deviations can be quickly spotted is essential. Overall, an automated data collection system improves product quality, compliance and organisational production within the bioprocessing industry.

Opvia’s data integration system is useful in both the short and long run to help bioprocessing companies have a competitive advantage and use technology to enhance their processes and product. Read more about it.

How can automated data collection help create digital twins for bioprocesses? 

CROs deal with various clients at the same time and each sample management process has different requirements

CROs deal with various clients at the same time and each sample management process has different requirements. Managing this whilst ensuring sample security and traceability is a challenge which is why more CROs are integrating automation and software solutions. This improves their throughput which is the time taken for a sample to pass from when sample receipt is produced to COA approval. 

## What are factors that affect a CRO’s throughput?

1. System integration: With the many stages of development, the integration between subsystems is integral to reduce time delays and inefficiencies. With the sample management software, an audit trail of the samples are created to make the process more trackables. Benefits of a software: 

   * Data is transferred between stages automatically, without the need for manual data handling or upkeep. 
   * Samples are tracked throughout the workflow and logged which reduces processing time, and data handling human errors. 
2. Customer communication: Creating a transparent development process is ideal so there is communication and collaboration between all the stakeholders involved which increases efficiency. Digital communication between the CRO and customer makes access to data faster, and customers can track the CRO’s progress. A software solution whilst making communication easier, also maintains confidentiality and data security with features like viewing controls. 
3. Automation: The implementation of automation with regards to the development procedures (i.e. data collection, sampling, etc.) improves efficiency and error tracking. When there are quality deviations, using the robust data and audit trail, tracing back to the individual errors is faster. 

![](media/screen-shot-2022-08-26-at-2.32.54-pm.png)



## How to implement a sample management system? 

Making the switch from manual sample management to automated software is a big change but offers many benefits and aligns a CRO towards Industry 4.0 principles. Automated software solutions consolidate all the sample data throughout their life-cycle onto a single repository. It can help to: 

1. Maintain traceability of all the samples. 
2. Log sample data and connect to smart sensors or analysers for data analytics features. 
3. Researchers and scientists working on the project collaborate effectively and easily access all sample data. 
4. Verify and validate data and sample processes. 

To implement this system, the integration of the technology requires these steps: 

1. Set up sample management procedures that can be embedded into the software. This is followed by the software to validate the samples and ensure the right steps are followed. 
2. Integrate smart sensors, device analysers into samples and directly transmit data into the software. This is used to track sample’s quality (i.e. expiry) and provide insights into the sampling process which a CRO can use to optimise their development process. 
3. Establish a feedback loop to optimise the development process. Using the data analytics, changes in the sample parameters can be controlled using the software. 
4. Use the software to communicate and collaborate with team members and external stakeholders. This ensures transparency within the development process and improves client relationships. 

![](media/screen-shot-2022-08-26-at-2.50.31-pm.png)

An automated sample management system helps a CRO optimise and manage their samples better. This improves the quality of the development process in a time-efficient manner.

How can automating sample management increase a CRO’s throughput?

The global pharmaceutical and biologics industries are becoming the fastest growing industries in the world

The global pharmaceutical and biologics industries are becoming the fastest growing industries in the world. To match the pace of discovery the CMO and CDMO industries are continuing to become more popular. 

In such a competitive industry, CMO/CDMOs must differentiate themselves to stand out. One such way is to build trust between long-term partners by adopting new quality-management technologies to ease concerns of process transparency and loss of control. The use of data analytics to make R&D processes efficient and controlled is being adopted by more CMOs to set themselves apart. 

### **What do your partners want and why adopt an automated data collection solution?** 

Companies that outsource their manufacturing aim to get their products developed in a cost-effective, fast and high quality manner.

![](media/screen-shot-2022-08-23-at-11.16.16-am.png)

1. **Efficiency:** In this competitive market, the company with the first-to-market product will be valued higher than others, so CDMOs must make their process and operations as efficient as possible. An automated data collection system helps here to maintain control of the processes, data whilst ensuring there are no deviations in the batch. 
2. **Integration Capabilities:** Due to the multiple stakeholders within the product’s supply chain, clients are looking for a CDMO to be able to integrate within the value chain from cell-line development to process analytics. Using a centralised platform, collaboration amongst various teams is possible in an easy, organised way. 
3. **Transparency:** When handing out research to external partners, clients lose significant control and visibility over their product. To ensure this does not cause unease to clients, promoting transparency is vital. A software solution makes this simpler by providing viewer controls along with real-time analytics of manufacturing progress. In addition, as the data is saved onto a cloud based platform, it is better protected and less prone to loss of intellectual property. 

![](media/screen-shot-2022-08-23-at-11.19.07-am.png)

### **How can data analytics set CMO/CDMOs apart from others?** 

Beyond having an efficient, organised software solution for all the data collected throughout the product’s lifecycle, the next step is to optimise these processes using data analytics. Data driven quality assurance creates an efficient feedback loop that reduces batch failures at CDMOs ensuring that the result is of high quality and safe to use. 

### **What data analytics techniques to use?** 

1. **Remote monitoring:** With the use of smart sensors, there is a vast amount of data today. Monitoring this and filtering to find what is important and the trends is essential and can be done in a quick manner using data analysis. Based on previous results or trends, data analytics can provide end users with insights that are not immediately obvious yet very important. 
2. **Immediate fault detection:** Data analytics have two roles with regards to fault detection: predicting where batches deviate from controlled, diagnostic data, and keeping track of maintenance records for equipment. 
3. **Root cause analysis:** This is the process of identifying the cause of a problem in order to then find the right solution. A systematic approach is taken to ensure that underlying issues are found and solved. 
4. **Process forecasting:** This is another process under predictive analytics where data is used to predict future events by identifying patterns within data. 

These data analytics can be implemented using automated data collection systems where all the data is connected to a single database along with having in-built analytics features. Opvia’s data integration solution allows companies to build their platform around their manufacturing process using templates and the ability to write code within the platform for analytics. Read more about our adaptable, software solution.

How data driven solutions can set apart CDMOs? 

A corrective and preventive action (CAPA) plan is a critical part of any quality management system


A corrective and preventive action (CAPA) plan is a critical part of any quality management system. This plan is used to identify and correct any manufacturing issues before they can cause bigger problems down the line. 

This article is about everything manufacturers need to know about creating a CAPA plan for their manufacturing process and how to implement it digitally using a quality management system. 

## What are CAPAs?

A corrective and preventive action, or CAPA, plan is a process manufacturers use to identify, correct and prevent quality issues. This plan is an important part of any quality management system, or QMS.

CAPAs can be triggered by many different things, such as customer complaints, failed product tests or process deviations. The goal of a CAPA plan is to identify the root cause of the problem and correct it, so the issue doesn't happen again.

A CAPA plan should be well-organised and have a clear workflow. It's also important to have a system in place for tracking the progress of each CAPA. This information can be stored in a quality management system, which can help manufacturers keep track of all their quality data in one place.

## How to create a CAPA workflow?

When it comes to creating a corrective and preventive action (CAPA) plan, there are a few key things to keep in mind. Manufacturers need to have a process in place for identifying and investigating potential quality issues, as well as for taking corrective and preventive action. Many manufacturers are hesitant to implement change, but with the right tools, it can be a relatively easy process.

The first step is to create a CAPA workflow within the manufacturing process. This will help track and monitor any issues that may arise. A quality management system can be invaluable in this process, as it will allow manufacturers to track and trend data digitally continuously.

This data can help identify patterns and trends, which in turn can help prevent future issues from happening. It's a continuous improvement cycle that will help manufacturers maintain compliance and improve the quality of their product.

## Why use an eQMS?

Why is it so important for manufacturers to have a CAPA plan in place? Quite simply, it's because a CAPA plan helps to ensure that quality defects are corrected and prevented from happening in the first place.

A CAPA plan is all about taking corrective and preventive action to improve the quality of the product. It's a way of streamlining the manufacturing process and making sure that defects are identified and corrected as quickly as possible.

But creating and implementing a CAPA plan can be a daunting task, especially when manufacturers are not sure where to start. That's where a quality management system comes in handy. A quality management system can help create and track CAPA workflows, making the entire process easier and more efficient. This is because many eQMS softwares have a set process to establish CAPA controls in an organised manner. This provides manufacturers a good starting point and then these controls can be customised to match a particular process. 

## Implementing a CAPA plan in the manufacturing process

First, manufacturers need to create a workflow that outlines the steps they need to take to correct and prevent problems. This workflow should be tailored to the specific manufacturing process, and it should be easy to follow so that everyone involved can understand it.

Once this workflow is in place, a system to track and manage corrective and preventive actions should be set up. This system should be digital, so manufacturers can easily access it from anywhere. And it should be easy to use so that anyone can input data and generate reports.

Finally, everyone involved in the manufacturing process should be aware of the CAPA plan and knows what their role is. At this stage manufacturers might want to consider training everyone on how to use the digital system for tracking and managing corrective and preventive actions.

A corrective and preventive action (CAPA) plan is a critical part of any effective quality management system (QMS). By implementing a CAPA plan, manufacturers can ensure that their products meet all required safety and quality standards. Read about Opvia’s quality management solution and sign up for a demo [here](https://www.opvia.io/contact).


How to implement a CAPA plan for your manufacturing process?

In-vitro diagnostics regulation (IVDR) is the regulatory framework and compliance assessments that pharmaceutical manufacturers follow to gain approval to bring their device to market

### What is IVDR?

In-vitro diagnostics regulation (IVDR) is the regulatory framework and compliance assessments that pharmaceutical manufacturers follow to gain approval to bring their device to market. 

In-vitro diagnostic medical devices are tests used on biological samples to determine a user’s health (i.e. blood glucose tests for diabetes, self-tests for pregnancy, etc.)

The IVDR regulation aims to improve clinical safety whilst being in line with the industry’s technological advances, changes in medical sciences. It focuses on transparency in the supply chain and post market surveillance. 

### What are the new regulations?

The regulatory frameworks for medical devices and IVDs are undergoing significant changes, and more manufacturers are looking to adapt their development and manufacturing processes to be compliant with these changes, and ensure the highest quality standards. The EU In Vitro Diagnostic Regulation 2017/746 will be brought to effect in 2022.

![](media/screen-shot-2022-08-04-at-9.41.22-am.png)

### The key changes the IVDR brings about are: 

* **Broader definition of IVDs:** Beyond tests and devices, the new regulation will include software solutions and companion diagnostics under the IVD category. 
* **New conformity assessment procedure:** With the new regulation, an IVD manufacturer needs to undergo a conformity assessment by a notified body to certify the product instead of just a self-certification. The notified bodies play a critical role in product approval, and data transfer between the two stakeholders is very important. Easy access to data while maintaining confidentiality is important and having an automated quality management system makes this easier using viewing controls. 
* **New risk-based system:** A new classification system with 4 categories will be used which defines the device’s risk characteristics. 

![](media/screen-shot-2022-08-04-at-9.41.14-am.png)

* **New requirements for clinical evidence, and performance studies:** Having adequate clinical and performance data to show the device’s conformity with the necessary safety requirements. The data is compiled into a performance report which includes a scientific validity report, analytical performance report, clinical performance analysis, and an assessment of these tests. Quantifying test results help’s justify the product’s performance and using a software solution, the collection and analysis of data using AI is much easier and more accurate. 
* **Post-market surveillance:** For the life-cycle management of the product, manufacturers are required to have a quality management system (QMS) in place and plan, document, implement and maintain a post-market surveillance analysis. 
* **New unique device identification:** For greater traceability of products, the IVDs are required to each have an unique device identifier (UDI). integrating this technology and maintaining a database of UDIs is possible only with a QMS system that can easily manage and track their various IVDs.

### Tips to comply with these new regulations?

With these new regulations, control and traceability of the supply chain is very important and using an automated quality management system (QMS) to help is beneficial. In-vitro devices require more quantifiable, analytical performance analysis than regular medical devices and the integration of a software solution can provide this. 

* Data analysis & AI: Used to collect and analyse manufacturing and product development data to provide analysis on device performance, and make root cause analysis easier. 
* Digital twins: Used to replicate the IVD’s supply chain or manufacturing process digitally to test its performance digitally. Can be used to understand the performance of a device in various environments, providing real-time analysis, predictive analytics, and accelerated risk assessments. 

Read more about Opvia’s quality management software solution [here](https://www.opvia.io/qds).

Navigating EU’s regulation changes in-vitro diagnostic medical devices  

Manufactures develop products by execution processes and so, there is a direct correlation between quality improvement and process improvement

Manufactures develop products by execution processes and so, there is a direct correlation between quality improvement and process improvement. Improvements in the product realisation processes improve the final product's quality. This is where quality management systems (QMS) are involved, because a QMS is simply a system that tracks, and controls all stages of the production process. Not only does this allow for easy quality control it also ensures continual quality improvements which provides a competitive edge to manufacturers.

## What is a QMS?

It is a system that aims to implement quality management within the company and consists of the necessary procedures, resources, and features to be able to do so. It documents, tracks and controls all the processes, procedures and workflows for the manufacturer to reach their quality objectives.

The QMS tracks:
1.  Quality policies
2.  CAPA workflows
3.  Documentations of design and development processes
4.  Certifications
5.  Standard operating procedures (SOPs)
6.  Mandatory documentation based on the particular industry

## Why implement a QMS?
There are two aspects of why manufacturers choose to implement a QMS - customer focus, and productivity gains.

From the customer’s perspective, implementing a QMS improves the quality of the product which in turn increases customer satisfaction and drives up sales. It also is able to provide manufactures a competitive edge in the fragmented manufacturing market. From the management perspective, the gain in productivity is very valuable to manufacturers to decrease their production costs and product time-to-market. So, implementing a QMS is a valuable tool for manufacturers to drive productivity and improve sales. However, the implementation of a QMS must drive from internal motivation rather than external pressures for the system to be effective because support from the workforce during the implementation stages is vital.

Short term benefits of a QMS system:
1. **Information control:** Without a QMS, critical process information is known to a few individuals and the company depends on them heavily. Instead, formal documentation on a QMS makes communication easier while reducing organisation vulnerability.   
2. **Waste reduction:** A QMS eliminates any resource wastage and drives up process efficiency. This reduces costs and wastage for manufacturers. In addition, with higher quality of product, batch failures or product recalls are reduced which further reduces waste.
3. **Greater collaboration:** A QMS integrates various stages of production and makes communication between teams much easier. This improves employee morale and the greater collaboration which have many benefits that drives up operational efficiency.
    
Long term benefits of a QMS system:
1. **Operational efficiency:** The QMS tracks all the stages of production against the predefined process. This predefined documentation is the basis for repetition which reduces deviations and improves operational efficiency.
2. **Closed feedback loop:** With a corrective and preventive action (CAPA) workflow established within the QMS, errors are quickly found and corrected. In the long run, this makes process optimisation and root cause analysis faster.   
3. **Fosters continuous improvement:** A QMS system has an integral role in performance analysis and this allows for continuous improvement of the production and its manufacturing. Data analytics makes trend spotting more insightful and helpful.
4. **Customer retention:** The focus of the QMS is improving quality of the product and this increases customer satisfaction, loyalty and retention. The product’s quality assurances are also a factor that can attract new customers.

## What is an eQMS?

An eQMS is an electronic system that maintains all the necessary documentation and quality procedures in an automated, efficient manner. On top of tracking all the data that a manual QMS does, an eQMS offers greater visibility and control over processes. With the focus on digitisation, an eQMS drives manufacturers to keep up with industry 4.0 aims.

An eQMS offers a single platform for all data and process management which facilitates auditing and product traceability.

## What are the benefits of an eQMS in comparison to a QMS?

The functions of both an eQMS and a QMS are the same, yet the methods of implementation and performance vary. With an eQMS it is easier to implement since software solutions come with in-built features (i.e. CAPA management, audit trail & report generation).

Features of an eQMS system:
1. **Corrective and preventive action (CAPA):** This is a tool that continuously collects and analyses data to quickly identify and solve quality issues or inefficiencies.
2. **Audit management:** The eQMS tool tracks all stages of production which creates an audit trail of the product from ideation to delivery. So, inspections and executing audits are easy and more efficient. With the digital solution, all data is stored in a centralised platform which also reduces the amount of labour needed to execute audits.
3. **Compliance regulation:** The quality and risk management controls in the QMS quickly identify hazards within the manufacturing process. This ensures high quality and compliance conformance. There are various regulations to comply with which depend on the industry of the product, but it is integral to follow them to reduce product recall.
4. **Statistical process control (SPC):** This is a feature of an eQMS that collects process performance data in real-time and analyses if there are any process or quality variations. This is very important to identify issues and take corrective action very quickly.

An eQMS solution is integral for manufacturers to improve their processes and ensure their products are quality focused. It also facilitates data management which has many benefits with regards to compliance, efficiency and productivity. Read about Opvia’s quality management solution and sign up for a demo [here](https://www.opvia.io/contact).


From CAPA workflows to quality assurance - A detailed guide of QMS and its impact of production processes

Electronic batch records are an essential part of the bioprocessing industry

Electronic batch records are an essential part of the bioprocessing industry. These records often include information about the process such as the material lot numbers, equipment identifications, yield calculations, and count reconciliations which are important to track and control in a high-risk industry such as this one.

The principles of Bioprocessing 4.0 is transforming the industry’s manufacturing processes and operations to improve workflow and the end product using digitization. This shift tackles 3 pain points in manual manufacturing processes: data integrity, single-use system risks, and data analysis & reporting.

Here’s an explanation of these and some tips on how the implementation of an EBR can help. 

1. **Data Integrity:** Maintaining the quality and integrity of data generated from a bioprocess is a large concern amongst manufacturers. In these bioprocesses, data moves across various stages and people. This complexity makes it necessary for strict compliance controls within any supporting system. 

   Bioprocesses also use Industrial Internet of Things (IIoT) devices such as smart sensors, and bioreactors that provide real time data and analytics. Data from these devices must also be transferred back to the system in an effective manner without any data alterations. 

   ![](media/screen-shot-2022-08-23-at-11.29.27-am.png)

   With an automated system, the secure movement of data can be ensured by using an EBR system that tracks all the data in an easy to understand setup. Choosing the correct system can be a challenge but a tip is to find a software that deals with data in an ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available) manner. 
2. **Single-Use System Risks:** The bioprocessing industry is rapidly switching to the use of single-use technologies which is the use of manufacturing equipment that is designed to be used once and then discarded. This removes cleaning, sterilisations, and sanitization steps within the process. 

   From a manufacturing perspective, this makes it difficult for data tracking and traceability due to the sheer number of components used. In addition, when restarting the manufacturing process, all the components need to be reconfigured, and checked for each batch. Thus, there is the need to have greater control over the manufacturing process and this is where an EBR can help. 

   A software solution is useful to ensure there is control over the data using procedure controls that make sure all the necessary steps have been carried out at the start of manufacturing a batch. Templates also allow rapid replication of a manufacturing process which makes the restarting and executing processes faster. 

![](media/screen-shot-2022-08-23-at-11.28.02-am.png)

2. **Data Analysis & Reporting:** A large aspect of bioprocesses and research is the comparison of batches against each other. Manually inputting data in a batch record has two downfalls: lack of real time data analytics and low data quality. Both of these can be solved using an EBR system which ensures the quality of data and its accuracy by setting controls within the data collection along with then analysing this data faster. After this analysis, consolidating it into reports is essential and this can be easily created using EBR software such as Opvia. 

The use of electronic batch records can help to improve safety by providing a more detailed account of what has been done in the process along with complying to the necessary guidelines such as the 21 CFR and cGMP. This will allow for better tracking of errors and prevent them from happening again in the future.

Opvia’s electronic batch records solution provides a more efficient way to make changes to processes that would otherwise be difficult or impossible with paper-based systems. Read more about it .

Top 3 pain points of a manufacturing process in the bioprocessing industry and how an EBR can help

The innovative capabilities of a bioprocessing company determines the company’s success, yet researchers spend too much time on looking for materials, routine inventory upkeep

The innovative capabilities of a bioprocessing company determines the company’s success, yet researchers spend too much time on looking for materials, routine inventory upkeep. Lab inventory management is an integral aspect yet often overlooked which can result in bioprocessing companies losing their competitive edge. A software solution to manage lab inventory lets companies: 

1. Buy supplies when needed 
2. Store all supply data in a single platform 
3. Minimise inventory investment
4. Reduce waste from expiration of materials

![](media/screen-shot-2022-08-23-at-11.32.02-am.png)

An assistive tool alongside researchers to facilitate product development is very useful to make a bioprocess more efficient, so the workforce focuses on more important tasks. An inventory and resource management system has benefits throughout the stages of development:

1. **Monitoring of lab inventory:** Upstream processing consists of the target cells being separated from its extracellular matrix using chemical reagents. A database of these reagents and their stock can be stored in an automated software that can easily be retrieved and updated. QR codes or barcodes on bottles and devices make it easy to quickly retrieve product data including safety, and storage information. Reordering and predictive analytics in a software ensures that stocks are reordered when necessary. 
2. **Regulatory compliance:** An automated inventory management software ensures transparency within the bioprocess. By constantly documenting the experimental setups, and reagents used an audit trail is established which ensures the product is compliant to all the necessary regulations (i.e. cGMP, GxP, etc.). Having this detailed information in a centralised platform makes verification of the bioprocess easier and facilitates root cause analysis for risk mitigation. 
3. **Process Optimisation:** With all the data collected in an inventory management system, data analytics and AI techniques are used to spot inefficiencies in the bioprocess to improve the product yield, quality and safety. This makes it easier to monitor, control and optimise the bioprocess and in the case of batch failure, risk mitigation and root cause analysis is faster. 

![](media/screen-shot-2022-08-23-at-11.31.49-am.png)

The integration of workflows with devices and laboratory inventory increases productivity, quality and traceability within the bioprocess. In addition, using data analytics to reduce time spent on manual, upkeep tasks is becoming popular in the bioprocessing industry that is using digitisation to innovate and provide companies a competitive advantage. Read more about Opvia’s resource and inventory management solution.

Top 3 tips for efficient lab inventory management for bioprocessing companies using an automated inventory and resource management system 

Batch failure is when a batch of a manufactured product is recalled due to either the product or the manufacturing process not adhering to the quality and safety requirements

Batch failure is when a batch of a manufactured product is recalled due to either the product or the manufacturing process not adhering to the quality and safety requirements. They are a common and expensive problem faced by the industry and the implementation of a software solution is an effective solution to manage the bioprocess.

![](media/screen-shot-2022-08-23-at-11.38.37-am.png)

### **The leading causes of batch failures are:** 

1. **Operator errors:** These are common human errors that result in a deviation from the procedure of a bioprocess. These are more difficult to stop and time to recruit, train, and retain the right operators is an issue. 
2. **Equipment failure/contamination:** In bioprocess, this is the microbial contamination of the mammalian cell cultures. 

### **Reducing human error with a PLM system.** 

Having a workforce with sufficient bioscience expertise  is difficult in this industry due to the intricacies within the development and manufacturing process.

Thus, providing the workforce with necessary guidance and training is the first step to reduce human error. Along with this, providing them with an understanding of the bioprocesses during development also creates a more skilled workforce. A PLM system can assist with: 

1. **Quality controls:** To achieve the desired yield results, quality assurance is necessary. With a PLM system, the required quality controls can be embedded into the templates used for collecting data. So, while the operators are inputting their data, these quality controls are brought up and used as an assistive tool to ensure steps are performed correctly.
2. **Root cause analysis:** This systematic approach takes into account the materials, machinery, measurements, training and environment to understand the cause of and eliminate human errors. The data from the PLM system is used for this and leads to more meaningful CAPAs (corrective and preventive actions).. 

### **Reducing equipment failures with a PLM system.** 

Reducing equipment failure is achieved by establishing a risk-based approach to the bioprocess which quickly spots defects or failures using data analytics. A PLM system helps here by establishing: 

1. **Predictive maintenance:** This is an important stage in PLM and helps bioprocess manufacturers determine the condition of their equipment, and predicts when maintenance is required. This makes sure the equipment used is of good quality and reduces unexpected failures. 
2. **Real-time maintenance:** During the daily process of development and manufacturing, data is collected and is used to spot defects or component failures quickly.

![](media/screen-shot-2022-08-23-at-11.38.56-am.png)

The features provided within a PLM software helps to reduce both human error and equipment failures and this reduces the chances of batch failures. Thus, using a PLM platform a bioprocessing company can optimise their manufacturing process along with monitoring post-market performance. Read more about Opvia’s PLM solution .

Using a PLM system to lower batch failures in bioprocessing

Medical device supply chains are increasingly complicated and interdisciplinary in terms of the stakeholders involved

Medical device supply chains are increasingly complicated and interdisciplinary in terms of the stakeholders involved. To innovate in such a competitive environment, traceability and quality management in all stages of development from ideation to market approval is vital. An integrated PLM software platform to track data, product development and optimising manufacturing processes has many benefits for medical device manufacturers. 

### **What are factors that affect a product’s time to market?** 

1. **Regulation:** The industry is heavily regulated with stringent laws to be followed with regards to safety and quality. Not adhering to any of these regulations can result in no approval from regulatory authorities or even product recalls. Implementing better regulatory and compliance strategies though PLM software is necessary. 

![](media/screen-shot-2022-07-26-at-5.06.58-pm.png)

2. **Collaboration:** With the significant number of people working on the development of a medical device, from hardware engineers, to product managers to researchers - communication becomes difficult. For all the teams working simultaneously in an efficient manner, a collaborative PLM software is ideal. Within the software, viewer controls along with traceability of the product development allows all teams to understand the product development process and exactly what each team is working on. Greater transparency and communication makes product development more time-efficient.  

![](media/screen-shot-2022-07-26-at-5.06.50-pm.png)

3. **Product Traceability:** Regulatory bodies (i.e. CFR Part 21) requires medical device manufacturers to track and produce the history of a product from creation to distribution. This is an important step in terms of compliance maintenance and can often be a time-consuming task. All of this information is compiled in a Design History File (DHF) and automated PLM systems with workflow control and traceability make creating this audit trail quicker and more accurate. Product information throughout the stages of development (i.e. lot numbers, batch numbers, etc.) is catalogued onto the system and can be quickly accessed and provide a roadmap of the product. 

The fragmented organisation structure of teams in the development of medical devices along with the regulatory complications, an efficient, automated PLM system has many benefits. The centralised platform is useful to create transparency and monitor product quality. These factors together make the medical device development process more productive and can reduce the time it takes to be approved and reach the market. Read more about Opvia’s PLM system with risk mitigation tools .

Using PLM to bring medical devices faster to market

The new medical device regulation (MDR) was released on 26 June, 2022 and sets new regulations aimed to improve patient safety, innovation and maintaining the UK's competitiveness in the global market

The new medical device regulation (MDR) was released on 26 June, 2022 and sets new regulations aimed to improve patient safety, innovation and maintaining the UK's competitiveness in the global market. This comes after Brexit, where UK regulatory bodies need to navigate changes and align with other internationally recognised best practices and standards. 

### What is the aim of these changes? 

* Strengthening MHRA’s role in patient safety
* Creating a more suitable environment for medical device innovation
* Reduce health inequalities throughout a medical device product lifecycle
* Regulations aligned with global standards (i.e. EU MDR, IMDRF)  which will support business worldwide

### What are the key changes? 

* **Accountability of manufacturers, importers and distributors:** The new regulations aim to improve the accountability of medical device manufacturers to improve the product safety. The new changes include: 

  * UK Responsible Persons (UKRP): qualified people that are liable for the defective medical devices, support regulatory compliance on the same basis as the manufacturer. 
  * Economic operators will analyse any issues that can interrupt supply chain or cause any shortage of medical devices and report this to the MHRA.
  * Fulfilment service providers (FSPs) will now have greater accountability of the supply chain of the medical device, taking in account risk of duplicated labelling or registration requirements. 
* **Traceability of devices:** Under the new regulations, each medical device will need to be registered with a unique device identifier (UDI) before being placed in the UK market. All these devices can be tracked and placed in a comprehensive registration database. 
* **Conformity assessment:** Changes to this assessment were made to ensure the assessment is more effective at assessing medical device safety, quality and performance. The changes include removing the option to use batch verification, and type examination for all devices. 
* **Alternate routes to market:** The new regulation changes recognises the need to support more routes to market and promote international collaboration. The MHRA plans to use the Medical Device Single Audit Program (MDSAP) certification and Domestic Assurances as alternative routes to market. In addition, for innovative MedTech devices the MHRA has introduced a pre-approval route. 
* **Clinical investigations and performance studies:** New regulations have detailed a range of more pre- and post market requirements for medical devices to enhance product safety. 
* **Post-market surveillance:** This is aimed to ensure better incident monitoring and reporting, and increased analysis of any post-market device deviations. More data collection and reporting will be required. 

### How to navigate these changes? 

With these new changes, medical device manufacturers will need to make their processes more transparent, accessible and adaptable to regulatory changes. The implementation of an automated quality management system can make medical device manufacturers better suited to demonstrate the safety and effectiveness of their device. The benefits of a software solution includes: 

* **Complete view of data:** With the new regulations, the need to assemble and analyse data faster in an organised manner is vital. An automated software can make data collection and storage easier making the quantification of data for performance studies more accurate. In addition, having it all in a central repository makes accessibility faster and establishes it as a single source of truth. 
* **Data insights:** Bringing in all the documentation necessary for regulatory approval in the correct formatting along with the justifications of the product safety and performance using data analytics is faster. Since it is automated, the rate of errors is reduced too. With the industry moving towards machine learning and AI, these techniques can be better implemented for predictive maintenance, or real-time analytics in an efficient way. 
* **Quality control:** With the focus on quality with the new regulations, a way for medical device manufacturers to control their product and its quality better is by creating an accurate audit trail of the device. This makes root cause analysis and deviation spotting faster.

![](media/screen-shot-2022-08-23-at-11.40.18-am.png)

An automated quality management system helps medical device manufactures navigate through regulation changes through the features they have to help integrate and make workflows more efficient. In addition, software solutions are more adaptable and constantly be iterated to optimise the device processes whilst enhancing its quality. Read more about Opvia’s quality control solutions [here](https://www.opvia.io/qds).

What are the new changes in MDR regulation by the MHRA?

The new EU Medical Devices Regulation (MDR) has been brought to application since 26th May 2021 following a four year transition period

The new EU Medical Devices Regulation (MDR) has been brought to application since 26th May 2021 following a four year transition period. The MDR outlines all the necessary regulations and documentation needed throughout the life-cycle of the device for it to gain approval. The new regulation introduces new procedures to improve the traceability, accountability and quality of medical devices.

New MDR changes are:

![](media/screen-shot-2022-08-23-at-11.41.14-am.png)

* **Labels:** There will be some changes to requirements for labels of medical devices. These changes include: 

  * **Reprocessing of single use devices:** The MDR has stringent guidelines for the reprocessing of single use devices. New regulations involve needing the legal name and address of the manufacturer reprocessing these devices.
  * **Unique device identification (UDI):** The UDI system has been established to make tracking of medical devices throughout the lifecycle much easier. The UDI carrier must be visible on the label as well. The integration of a UDI system with a quality management system is useful because it makes data tracking and management easier with lower human error rates. 
  * **Disrupting substances:** Indication of any carcinogenic, mutagenic, or toxic substances must be added on the label. This does not necessarily make the device unsafe but instead if justified the use of the substance is permissible. 
* **Instruction for use (IFU):** New regulations identify the information that must be included in the IFU to inform the user of the device’s intended use and purpose. 
* **Certificates from a notified body:** In the new MDR, self certification is no longer applicable, and the device must be certified by a third party. These bodies must have a notified body certificate issued by the MDR and they have a critical role in providing manufacturers with a seal of approval. This step requires an efficient data transfer manner that is transparent, collaborative and confidential which is easier with an electronic software. 
* **Declaration of conformity (DoC):** New DoCs will be issued under the MDR. This requires additional information from the manufacturer and strengthens the quality and safety of the product. 
* **European Database of Medical Devices (EUDAMED)**: Previously, this database was only accessible to regulators but will now be accessible publicly. 
* **Post market surveillance:** There is an increase in post-market analysis and surveillance of medical devices including post-marketing clinical follow up data, publishing a periodic safety update report. Alongside this, robust surveillance procedures should also be implemented to be able to detect and collect data on any adverse effects of the device in clinical practice. Data collection and analytics is very useful here and can provide insights useful to comply with regulations and also help optimise the medical device manufacturing process. 

The new MDR presents many features that promise to deliver safer medical devices especially with high-risk or implantable devices. In addition, the implements of UDIs and the EUDAMED database will improve transparency in the industry and the medical device’s supply chain. To comply with these new rules, manufacturers must be able to adapt their processes to set mechanisms to improve traceability and data collection. Using a quality data system (QDS) for this is a way to integrate workflows in an efficient, data driven manner. Read more about Opvia’s quality data system [here](https://www.opvia.io/qds).

What are the new MDR changes and how does a medical device manufacturer comply with these changes? 

With the constant change in consumer tastes and preferences, companies in the industry are constantly increasing their product offerings

With the constant change in consumer tastes and preferences, companies in the industry are constantly increasing their product offerings. There is the strong need to constantly innovate quickly to beat competitors in a heavily fragmented market. 

### **What does a digital recipe management system look like?** 

An automated data collection system for recipe development and management is where all data regarding the product is stored. From concept generation, to prototype production and product launch, all the progress can be tracked in this centralised, digital format. 

### **How does this system help in the stages of product development in this industry?** 

1. **Consumer testing:** Target consumers test the product to determine whether the product is liked by the consumer. This can include having specific targeted groups (i.e. people of a certain age, allergies, etc.), sending tests to people’s homes or taste testing in public places (i.e. supermarkets). Storing consumer data, feedback is an important part of the evaluation process. With the collected data, analysis to find trends can be done on a software solution where the data can be visualised in a simpler manner. 
2. **Finalisation of product specification:** Consumer feedback is fed back into the product development to modify it to ensure it meets the needs of the consumer. All the finalised ingredients, and substance data that is not stored in the Bill of Materials can be stored into the software’s centralised database. It is also easier to then share this information with manufacturing teams to ensure that mass-production is done correctly. 
3. **Market testing:** The product is ready to launch in the market and now scaling up of operations is necessary. After the launch, the product’s sales performance is analysed. Software solutions offer data analytics which can make this process much faster, and insightful. 

### **What are the benefits of this system?** 

1. **Protection of data:** Digitally storing recipes in a secure system where unauthorised parties cannot see the information keeps data confidential and safe. 
2. **Consistency of product:** Consumers expect consistency in quality and taste of these products and this is necessary to build a loyal customer base. Following the recipe to the tee and keeping errors to a minimum is crucial and this is easier to achieve when manufacturing follows a digital, controlled system. The system can make sure the same recipe is followed exactly, with ingredient quantities, cooking times and temperatures are exactly what they should be. So, human error is minimised along with in the case of deviations, it can be spotted quicker using an automated system. 
3. **Product development:** Using a digital system also provides data analytics features that analyses the manufacturing process, the product and its quality. This can provide insights into the product and ways to optimise the manufacturing processes. 
4. **Compliance:** An automated system for data collections enforces regulatory compliance at facility with consistent alerts for allergens, and precise ingredient quantities. 
5. **Real time data:** The process of accounting ingredient consumption and inventory is easily updated through a digital interface. This makes the process more transparent where stock levels and progress can quickly be found. 

New product development is a complex process and the product must meet the necessary quality requirements whilst differentiating itself from similar products. This is where digital tools can help and automate product development which reduces the company’s cost. When creating a new product, the focus is on the recipe due the importance it can have in shaping the brand’s identity and driving sales. 

A dedicated food recipe management system is useful to perfect, protect and consistently apply the product formulas. An automated data collection system can help collect all the data during the development of a product in a standardised manner. Read more about Opvia's automatic data collection software.

What are ways to digitise recipe development using an automated data collection system?

Electronic batch recording (EBR) is a process used in biopharmaceutical manufacturing to track and record production data

Electronic batch recording (EBR) is a process used in biopharmaceutical manufacturing to track and record production data. EBR systems are typically used to record data related to the production of pharmaceuticals and medical devices. The data collected by EBR systems can be used to track production trends, optimise manufacturing processes, and ensure quality control. EBR systems can also be used to support regulatory compliance. 

### **What is the difference between a paper and electronic batch record?**

![](media/screen-shot-2022-08-23-at-11.43.05-am.png)

### **What is the purpose of an EBR system in this industry?**

![](media/screen-shot-2022-08-23-at-11.43.37-am.png)

### **What are the benefits of an EBR system in a biopharma process?** 

* **Data collection:** Data is collected during the process in an intuitive workflow consisting of manual inputs and automatic capture. At every step of the process, the system enforces predefined rules to ensure there are no input errors. 
* **Inventory management:** The electronic system enforces critical lot attributes to ensure that the right quantity of the right material is used in each step of the process. 
* **Communication:** The system allows for seamless communication between all stages of the process and order statuses. 
* **Quality review:** The system flags deviations in quality to be reviewed before it becomes a bigger issue. Using the ‘Review by Exception’ protocol this process is faster and more efficient. 

**\
What are the regulatory requirements for companies in this industry?** 

* [ISA-95](https://www.isa.org/standards-and-publications/isa-standards/isa-standards-committees/isa95): This is the international standard for the integration of enterprise and control systems such as the ERB system. 
* [GAMP 5](https://ispe.org/initiatives/regulatory/what-gamp): Industry guidance on achieving compliant computer systems for their intended use. 
* [GxP](https://www.cognidox.com/the-guide-to-gxp-compliance#:~:text=GxP%20refers%20to%20the%20'good,are%20safe%2C%20effective%20and%20usable.): Quality guidelines for bio/pharmaceutical products to ensure they are safe to use, meet their intended need, and have adhered to all the required quality procedures during the manufacturing process.
* [cGMP](https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations): Similar to GMP guidelines, these are also guidelines regarding the quality of the manufacturing processes, and packaging of the product. 
* [21 CFR Part 11](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application): These regulations outline the guidelines for electronic signatures and records. 

In recent years, the use of EBR systems has increased in the biopharmaceutical industry, as manufacturers have increasingly adopted EBR technologies to improve manufacturing efficiency and quality control. 

Opvia’s no-code software solutions for EBR are flexible to fit any design process along with being an efficient, traceable solution. Read more about it .

What does using an EBR system in the biopharma industry look like?

Bioprocesses rely on the constant monitoring and control of critical process parameters (CPPs) to ensure that a product is safe and of the highest quality

Bioprocesses rely on the constant monitoring and control of critical process parameters (CPPs) to ensure that a product is safe and of the highest quality. The most widespread method for process monitoring is sample based monitoring. Traditionally, bioprocessing companies used manual sampling tools which have major disadvantages: 

1. Risk of contamination of the process and sample because of improper handling, storage or usage of non-sterile equipment.
2. Human errors and deviations during sampling 

![](media/screen-shot-2022-08-23-at-11.44.50-am.png)

1. No real time data 
2. Paper-based and error prone data management system 

In order to solve these issues, bioprocessing companies are moving to an automated sampling method that ensures greater quality and management of the samples and data.

### **What is automated sampling?** 

An automated sampling system automates the transfer of bioprocess samples directly from bioreactors to analytical devices whilst maintaining process sterility. From a bioprocessing company’s perspective, this offers an insight into the bioprocess and what happens in the bioreactor which is very beneficial. In addition, the storage of this data into a central platform makes it possible for further process analysis and optimisation. 

### **What are the benefits of automated sampling?** 

1. **Integrations of analysers:** Analysers (i.e. cell counters, enzymatic analysers, etc.) connected to bioreactors can provide data analysis capabilities. This is orchestrated by a sample management software that is connected to these devices and triggers the measurement and transfer of data and analytics results.
2. **Feedback control:** Based on the analytics from analysers, establishing a feedback mechanism back to the bioreactors allows companies to optimise their process and identify areas of improvement. The two aspects to consider with regards to feedback control are: 

   * Sample rate: This is how many samples are taken per unit time by defining the acceptable time delay. The more often that data is collected, the greeted need for control, and tighter the control range to be set. 
   * Software interface between sampling system and bioreactor: The measurements of sampling rate, and time delays are controlled using the software interface. The transfer of data to change these parameters on the bioreactor can be done efficiently using software, so this interface is integral for the implementation of a feedback system. 
3. **Flexibility:** Each bioprocess has different requirements, and parameters, and the flexibility to change these quickly increases the bioprocessing company’s productivity. Using a software solution, making these changes are easy and offers greater remote capabilities as well. Samples travel through various locations and tracking and monitoring them is easy on an accessible software.  

### **How can automated sampling be implemented?** 

The switch to an automated sampling system requires: 

1. **Process analysers:** Devices that connect to samples, bioreactors to provide analytical data (i.e. Vi-CELL cell viability analysers, etc.) is vital to automate sampling, and develop a feedback loop. 
2. **Software solution:** Needed to store data for the analysers and enhance data analytics capabilities. The interface is also important to be able to communicate with the equipment to easily control and monitor the bioprocess. 

![](media/screen-shot-2022-08-23-at-11.45.11-am.png)

Sampling automation will make bioprocessing more efficient, helping make the manufacturing process and supply chain more continuous. It will also provide companies the ability to monitor the product’s CPPs and critical quality attributes (CQAs). This reduces the risk of contamination and human errors resulting in a safer, consistent bioproduct. Read more about Opvia’s sample management software solution.

What is automated sampling and what are its benefits to the bioprocessing industry?

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