- 14 Oct, 202321 minute read
A 7-Step Guide to Building a FAIR and Regulatory-Compliant Ontology: Mobilizing Data for Bioprocess Excellence
In the intricate and highly regulated world of bioprocess development and manufacturing, data is more than just a byproduct—it's a critical asset. The complexities involved in developing and manufacturing biotherapeutics, vaccines, and other biological products are immense.William MossCEO at Opvia - 10 Oct, 20237 minute read
5 Tips to Implement a Quality Management System
How can my company deliver peak productivity, high product quality, and strong compliance with industry standards? How can I simplify the complexities of internal policies, processes, and procedures? These are common questions that come up to those in quality management or compliance.Thomas OwenPharmaceuticals at Opvia - 10 Oct, 20234 minute read
What is a QMS and why should you use one?
When it comes to tracking quality, often times Quality Managers find themselves struggling with paper processes, or indebted to the dreaded process we call “Folder Hopping”.Luke JenemaBusiness Development Manager at Opvia - 6 Oct, 20235 minute read
Unlock the Potential of Quality Management Systems
In the dynamic and highly regulated fields of biotechnology and pharmaceuticals, ensuring product quality is of paramount importance. A robust quality management system (QMS) is a fundamental component of this endeavour, offering a structured approach to guaranteeing that every aspect of product development, manufacturing, and distribution meets the highest standards.Thomas OwenPharmaceuticals at Opvia - 3 Oct, 20234 minute read
How electronic batch records facilitate the implementation of AI techniques
AI can help identify inefficiencies in manufacturing processes and suggest ways to optimise them. AI can also be used to monitor production data and make predictions about future outcomes.Rachel LimCDMO/CROs at Opvia - 02 Oct, 20234 minute read
Avoid These 5 Common Pitfalls When Implementing Electronic Document Management in Food and Beverage Manufacturing
In today's fast-paced food and beverage manufacturing industry, staying ahead means embracing digital transformation. Electronic Document Management Systems (EDMS) are the backbone of efficient operations, ensuring compliance, streamlining workflows, and enhancing productivity.Thomas OwenPharmaceuticals at Opvia - 01 Oct, 20237 minute read
Why should you switch to electronic batch records?
In a manufacturing landscape characterized by stringent regulations, quality control, and the ever-pressing need for efficiency, accurate documentation and data management are paramount.Rachel LimCDMO/CROs at Opvia - 14 Sep, 20232 minute read
How an electronic batch recording system helps with CAPA planning
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.Rachel LimCDMO/CROs at Opvia - 13 Sep, 20234 minute read
Documenting Success: Crucial Forms for Regulatory Adherence in Canada's Cannabis Sector
Canada's cannabis industry has undergone a profound transformation, propelled by regulatory frameworks enforced by Health Canada. As the nation embraced the legalization of cannabis for medical and recreational use, the regulatory body, Health Canada, established stringent guidelines to ensure quality, safety, and compliance within this burgeoning sector.Alberto Frias FernandezF&B Expert at Opvia - 2 Sep, 20235 minute read
What are the EU regulations to comply with for EBRs?
Explore the complexities of European Union regulations governing Electronic Batch Records (EBRs) in our comprehensive guide. From GDPR to ISO/IEC 27001, this in-depth article outlines the scope, compliance requirements, and record-keeping obligations for each key regulation affecting EBRs.Rachel LimCDMO/CROs at Opvia - 01 Sep, 20235 minute read
Top 5 benefits of electronic batch records
In today's highly regulated manufacturing environment, accurate documentation and data management are crucial for compliance and operational excellence. This is particularly true for industries like pharmaceuticals, food and beverages, and chemicals, where batch processing is a core part of the manufacturing workflow.Rachel LimCDMO/CROs at Opvia - 28 Aug, 20234 minute read
The Crucial Role of Document Management Systems in Empowering Social Enterprises
In the realm of social enterprises where the pursuit of social impact intertwines with business sustainability, the significance of streamlined operations cannot be overstated.Alberto Frias FernandezF&B Expert at Opvia - 14 Aug, 20232 minute read
How an electronic batch recording software can help with DES models
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.Rachel LimCDMO/CROs at Opvia - 08 Aug, 202310 minute read
The Essential KPIs to Automate from Your EBR – Transform the Quality and Efficiency of Your Manufacturing
The manufacturing sector has never been more complex, especially in highly regulated industries such as pharmaceuticals, biotechnology, food, and beverages. As regulatory pressures mount and consumer expectations rise, companies in these sectors are turning towards technology to help them navigate these challenges.Rachel LimCDMO/CROs at Opvia - 3 Aug, 20234 minute read
The API development process and how an EBR can help
When it comes to developing active pharmaceutical ingredients (APIs), efficiency and reliability are key. That's where an electronic batch record comes in.Rachel LimCDMO/CROs at Opvia - 13 Jul, 20234 minute read
Driving Progress in Plastics Research: Enhancing Efficiency and Innovation
In the ever-evolving field of plastics and compounding, researchers face the challenge of developing new materials with improved performance, sustainability, and cost-effectiveness.Thomas OwenPharmaceuticals at Opvia - 03 July, 20237 minute read
How to Implement Electronic Batch Records in a Brewery: An In-Depth Guide
In the brewing industry, the marriage between tradition and technology can be a complex but rewarding relationship. This is especially true when it comes to integrating Electronic Batch Records (EBRs) into brewing processes.Rachel LimCDMO/CROs at Opvia - 30 Jun, 20234 minute read
Advancing Cosmetics Research: Accelerating Innovation and Sustainability
In the dynamic world of cosmetics and consumer goods, staying ahead of market demands and continuously innovating is crucial for success. Cosmetics R&D companies are constantly exploring new ingredients, formulations, and technologies to develop products that resonate with consumers and align with sustainability goals.Rachel LimCDMO/CROs at Opvia - 16 Jun, 20235 minute read
What to look for in a Scientific Data Management System (SDMS)
In today's data-driven world, scientific research and discoveries heavily rely on the collection, storage, and analysis of vast amounts of data. As data volumes continue to grow exponentially, the need for an efficient and robust scientific data management system becomes imperative.Thomas OwenPharmaceuticals at Opvia - 8 June, 20233 minute read
Step Off the Paper Trail: How a Switch to Cloud Uplifted One Winery's Operations (and Spirits!)
Let's cut to the chase—you're not just running a winery. You're wading through a logistical swamp of paper trails, decentralized Word docs, and clunky Excel spreadsheets.Thomas OwenPharmaceuticals at Opvia - 06 Jun, 20233 minute read
What to look for in an electronic batch record 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.Rachel LimCDMO/CROs at Opvia - 02 Jun, 20234 minute read
Top 3 pain points of a manufacturing process in the bioprocessing industry and how an EBR can help
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.Rachel LimCDMO/CROs at Opvia - 30 May, 20233 minute read
Best Practices for a perfect EBR for CDMOs
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.Rachel LimCDMO/CROs at Opvia - 28 May, 20237 minute read
Chat-GPT and Dall-E have taken the world by storm in recent months but can generative AI navigate the complexities of the biotech industry?
Generative AI, also known as deep learning, is a form of artificial intelligence that has altered the direction of biotechnology in recent years. With the ability to generate new data sets, create novel molecules, and predict protein structures, the technology has proven to be an invaluable tool for researchers looking to create new drugs, optimise production processes, and identify biological phenomena.Thomas OwenPharmaceuticals at Opvia - 25 May, 20232 minute read
Cell Therapy Manufacturing
Cell therapies are highly complex and personalised treatments, involving the manipulation and administration of living cells to patients. Batch records serve as a detailed documentation of the entire manufacturing process, capturing critical information such as cell sourcing, cultivation, processing and quality control measures.Thomas OwenPharmaceuticals at Opvia - 25 May, 20232 minute read
Determining EC50s
Testing dose responses from candidate compounds play a crucial role in pharmaceutical research and development, as well as in clinical practice. They help us understand the potency and efficacy of a drug, optimising dosing regiments and ensuring patient safety.Thomas OwenPharmaceuticals at Opvia - 25 May, 20234 minute read
EC50 v LogP
In the field of drug discovery, the identification and development of novel compounds with desired pharmacological properties is a complex and challenging task. One crucial aspect of this process involves comparing the EC50 (half-maximal effective concentration) and LogP (octanol-water partition coefficient) values for various candidate compounds.Thomas OwenPharmaceuticals at Opvia - 25 May, 20231 minute read
Endocrine In Vivo Studies
Hormones play a critical role in regulating various physiological processes and maintaining homeostasis in the body. By assessing the impact of drug compounds on hormone levels, researchers can gain insights into the compound’s potential effects on endocrine function, hormonal balance and overall health.Thomas OwenPharmaceuticals at Opvia - 20 May, 202313 minute read
What are the FDA regulations to comply with for EBRs?
In today's highly digitalized world, Electronic Batch Records (EBRs) have become an essential component for maintaining data integrity and ensuring compliance in various regulated industries.Rachel LimCDMO/CROs at Opvia - 20 May, 202330 minute read
Ensuring Optimal Data Integrity in Electronic Batch Records: A Comprehensive Guide
In industries where manufacturing processes are both complex and subject to stringent regulatory oversight—like pharmaceuticals, food production, and chemicals—the need for impeccable data integrity cannot be overstated.Rachel LimCDMO/CROs at Opvia - 17 May, 20236 minute read
How can an EBR help with the implementation of industry 4.0 aims?
The Fourth Industrial Revolution represents a paradigm shift in the way industries, especially manufacturing, operate. Fusing advanced technologies like the Internet of Things (IoT), Artificial Intelligence (AI), big data analytics, and cloud computing with existing infrastructures, Industry 4.0 promises unprecedented levels of efficiency and customization.Rachel LimCDMO/CROs at Opvia - 09 May, 20233 minute read
Streamlining the batch record process with EBRs: a how-to guide for biotech companies
Bioprocesses are complex and require high qualoty standards that must be managed and controlled efficiently. EBRs are a great option are offer many advantages including: - Speed up the process - Improve accuracy and compliance - Makes data entry easier.Thomas OwenPharmaceuticals at Opvia - 07 May, 20232 minute read
How can electronic batch records enable you to achieve pharma 4.0 objectives?
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.Thomas OwenPharmaceuticals at Opvia - 06 May, 20239 minute read
What are the benefits of an electronic batch record system for cell-based foods?
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.Thomas OwenPharmaceuticals at Opvia - 03 May, 20233 minute read
3 ways an electronic batch recording system can improve manufacturing yield
When it comes to manufacturing yield, even the slightest variation can result in a significant impact on production output. So, it's essential to have a process in place that can effectively manage and monitor these variations.Thomas OwenPharmaceuticals at Opvia - 02 May, 20232 minute read
What are EBR best practices for validation and implementation?
EBRs are digital records of all the data pertaining to a product's development. They help to ensure that all the steps in the product development process are documented, tracked and validated.Thomas OwenPharmaceuticals at Opvia - 28 Feb, 20233 minute read
How can automated data collection help create digital twins for bioprocesses?
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.Thomas OwenPharmaceuticals at Opvia - 28 Feb, 20234 minute read
How can automating sample management increase a CRO’s throughput?
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.Thomas OwenPharmaceuticals at Opvia - 28 Feb, 20235 minute read
How should you implement a CAPA plan for your manufacturing process?
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.Thomas OwenPharmaceuticals at Opvia - 27 Feb, 20233 minute read
Top 3 tips for efficient lab inventory management for bioprocessing companies using an automated inventory and resource management system
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.Thomas OwenPharmaceuticals at Opvia - 26 Feb, 20238 minute read
The Lab-Grown Revolution: Redefining the Future of Materials
Materials play a crucial role in our daily lives. They’re used to build our homes, manufacture our electronics and create our clothing. However, the use of materials and their manufacturing methods have become unsustainable, with serious consequences for the environment and society.Thomas OwenPharmaceuticals at Opvia - 24 Feb, 20233 minute read
Using a PLM system to lower batch failures in bioprocessing
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.Thomas OwenPharmaceuticals at Opvia - 24 Feb, 20233 minute read
Using PLM to bring medical devices faster to market
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.Thomas OwenPharmaceuticals at Opvia - 22 Feb, 20233 minute read
What does using an EBR system in the biopharma industry look like?
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.Thomas OwenPharmaceuticals at Opvia - 21 Feb, 20234 minute read
What is automated sampling and what are its benefits to the bioprocessing industry?
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.Thomas OwenPharmaceuticals at Opvia - 20 Feb, 20233 minute read
How does an EBR help with faster batch record reviews in the pharmaceutical industry?
The pharmaceutical industry is one of the most sensitive industries when it comes to product recalls. This is because a recall can have a huge negative impact on not only the company's reputation, but also on the health of its customers.Rachel LimCDMO/CROs at Opvia - 20 Feb, 20238 minute read
Why should process manufacturers consider an electronic batch record (EBR) system?
In any production line across the therapeutics, medicines, drugs, and even food and beverage sector, manufacturing in large batches (often known as batch manufacturing) is often adopted.Thomas OwenPharmaceuticals at Opvia - 14 Jan, 20234 minute read
What's the difference between an electronic batch record and a medical device history record?
When it comes to manufacturing and quality control in various industries, two essential types of documentation play critical roles: the Electronic Batch Record (EBR) and the Medical Device History Record (MDHR).Rachel LimCDMO/CROs at Opvia - 11 Oct, 20223 minute read
Benefits of using an EBR in the food and beverage industry
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.Alberto Frias FernandezF&B Expert at Opvia - 11 Oct, 20225 minute read
Unleash the Power of Automations: 10 Spectacular Biotech Visualisations You Can Build With Opvia
At Opvia, we make it possible for companies to automate the development, scale-up, and production of life-changing products, so they can become a reality within months, not decades.Rachel LimCDMO/CROs at Opvia - 07 Oct, 20224 minute read
Optimising inventory planning through a product lifecycle management (PLM) system
Inventory planning is an integral aspect of business planning. Manufacturers need to know how much product to order and when to order it in order to keep their shelves stocked and profits high.Alberto Frias FernandezF&B Expert at Opvia - 4 Oct, 20224 minute read
From data collection to insights - How automated data systems can improve manufacturing
Gaining real-time insights into the performance of a process is useful to manufactures to be able to identify problems and address them before they became costly and time-consuming.Alberto Frias FernandezF&B Expert at Opvia
