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Access the latest industry insights, expert guidance, and practical resources, and engage with interactive learning materials to address challenges and advance your professional development.
  • Good distribution practices: a guide to GDP compliance
    13 Jun, 2024
    16 minute read

    Good distribution practices: a guide to GDP compliance

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    Tali Kauffmann
    Product Marketer at Opvia

    Good Distribution Practices (GDP) are vital in the pharmaceutical industry to make sure products are handled, stored, and transported safely throughout the supply chain.

  • Top 15 life sciences conferences to attend in 2024
    12 Jun, 2024
    15 minute read

    Top 15 life sciences conferences to attend in 2024

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    Tali Kauffmann
    Product Marketer at Opvia

    The life sciences industry is always changing and growing, covering areas like biotechnology, pharmaceuticals, medical devices, and healthcare. For professionals in this field, it's important to keep up with the latest advancements, trends, and regulatory updates.

  • Why QMS is Dead
    07 Jun, 2024
    12 minute read

    Why QMS is Dead

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    William Moss
    CEO at Opvia

    For decades, Quality Management Systems (QMS) have been the cornerstone of quality and compliance in the life sciences industry. However, as technology advances and the pace of innovation accelerates, these traditional systems are increasingly becoming relics of the past.

  • 21 CFR Part 11 Compliance: Complete Guide [free checklist]
    06 Jun, 2024
    12 minute read

    21 CFR Part 11 Compliance: Complete Guide [free checklist]

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    Tali Kauffmann
    Product Marketer at Opvia

    Staying compliant with FDA 21 CFR Part 11 is crucial for keeping data accurate and secure in life sciences industries. This guide breaks down everything you need to know about 21 CFR Part 11, including key requirements, common challenges, and practical tips.

  • How much does ISO 9001 certification cost? [Comprehensive Guide 2024]
    06 Jun, 2024
    12 minute read

    How much does ISO 9001 certification cost? [Comprehensive Guide 2024]

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    Tali Kauffmann
    Product Marketer at Opvia

    ISO 9001 certification is a globally recognised standard that ensures your business meets high-quality management principles. While the certification process can seem daunting, understanding the costs involved can help you plan better.

  • Introducing Opvia’s Free Procedure Management System - Build Your QMS in 4 Easy Steps
    06 Jun, 2024
    6 minute read

    Introducing Opvia’s Free Procedure Management System - Build Your QMS in 4 Easy Steps

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    Orian Peled
    Software Engineer at Opvia

    At Opvia, our mission is simple yet ambitious: we aim to empower companies across various industries to deliver life-changing products in days, not decades. To achieve this, we've developed a single system-of-record that seamlessly connects procedures to executions.

  • Opvia partners with IMU Biosciences to support immune profiling innovation
    05 Jun, 2024
    2 minute read

    Opvia partners with IMU Biosciences to support immune profiling innovation

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    Tali Kauffmann
    Product Marketer at Opvia

    Opvia, a leader in quality management solutions, announced today that it has signed an agreement with IMU Biosciences (‘IMU’), a biotechnology company unlocking systems level immune data and AI to advance precision medicine, to provide Electronic Quality Management System (‘eQMS’) services.

  • 503a vs 503b: Understanding the Key Differences
    31 May, 2024
    6 minute read

    503a vs 503b: Understanding the Key Differences

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    Bridget Withers
    Founder Associate at Opvia

    Pharmaceutical compounding enables customisation of medications for specific patient needs and is crucial in the healthcare industry. The landscape of compounding is regulated by distinct frameworks, namely 503a and 503b, each with its unique requirements and standards.

  • What the FDA’s new Laboratory Developed Test (LDT) Regulations mean for your lab
    31 May, 2024
    8 minute read

    What the FDA’s new Laboratory Developed Test (LDT) Regulations mean for your lab

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    Wiktoria Bulik
    Pharmaceuticals at Opvia

    In recent years, Laboratory Developed Tests (LDTs) have garnered significant attention, particularly during the COVID-19 pandemic. If you’ve had a COVID-19 test or undergone genetic testing, it was likely an LDT.

  • cGMP and GLP: understanding the key differences
    29 May, 2024
    8 minute read

    cGMP and GLP: understanding the key differences

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    Tali Kauffmann
    Product Marketer at Opvia

    There are two essential regulatory frameworks that help achieve high levels of compliance and quality in the pharmaceutical industry. These are Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

  • Quality Control vs Quality Assurance (QA vs QC): key differences explained
    29 May, 2024
    7 minute read

    Quality Control vs Quality Assurance (QA vs QC): key differences explained

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    Tali Kauffmann
    Product Marketer at Opvia

    Understanding the differences between Quality Assurance (QA) and Quality Control (QC) is essential for effective quality management. While QA focuses on preventing defects through process improvements, QC concentrates on identifying and correcting defects in final products.

  • ISO 9001 vs ISO 13485: what are the key differences?
    28 May, 2024
    8 minute read

    ISO 9001 vs ISO 13485: what are the key differences?

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    Ivor Langley
    Solutions Consultant at Opvia

    What are ISO standards 9001 and 13485, and what do they cover? This article aims to answer those questions and to highlight the key differences between the two. ISO (the International Organisation for Standardisation) is a worldwide, independent, non-governmental standard development organisation, made up of representatives from each of its member countries.

  • Clinical quality assurance: the complete guide
    23 May, 2024
    12 minute read

    Clinical quality assurance: the complete guide

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    Tali Kauffmann
    Product Marketer at Opvia

    Clinical Quality Assurance (CQA) plays a crucial role in clinical trials and healthcare. It involves different practices and tools aimed at making sure clinical research and healthcare services follow high quality standards.

  • Lab digitalisation: why strategise before exploring?
    16 May, 2024
    7 minute read

    Lab digitalisation: why strategise before exploring?

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    Yaasir Suleiman
    Pharmaceuticals at Opvia

    Lab digitalisation is here to stay. But the increasing uptake of ELN and LIMS solutions isn't just a response to the demand for standardised workflows and ensuring regulatory compliance; it's how companies use automation to scale and stay innovative.

  • What is GMP Software?
    14 May, 2024
    14 minute read

    What is GMP Software?

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    Tali Kauffmann
    Product Marketer at Opvia

    Quality and compliance in manufacturing are essential. Good Manufacturing Practice (GMP) is the standard that helps achieve this.

  • What is automated data processing?
    09 May, 2024
    11 minute read

    What is automated data processing?

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    Mina Ilieva
    Data Integration Expert at Opvia

    Modern companies in regulated industries, like manufacturing and pharmaceuticals, need to make data-driven decisions quickly and securely. To gain a competitive edge, enterprises need efficient systems to store and process data, particularly as they adopt AI.

  • The complete guide: ISO 13485 certification for medical device manufacturing
    07 May, 2024
    13 minute read

    The complete guide: ISO 13485 certification for medical device manufacturing

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    Tali Kauffmann
    Product Marketer at Opvia

    For medical device manufacturing, quality and compliance are crucial. An essential standard for any company hoping to bring a medical device to market is the ISO 13485 certification.  ISO 13485 is a voluntary iso intended to help organisations design systems that consistently produce high-quality medical devices.

  • 11+ compliance and risk management courses for quality managers
    02 May, 2024
    15 minute read

    11+ compliance and risk management courses for quality managers

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    Tali Kauffmann
    Product Marketer at Opvia

    Quality managers are at the frontline of safeguarding an enterprise's integrity. Whether in pharmaceuticals, biotech, food and beverage, medical devices, or any industry with a need for serious regulatory compliance, being equipped with the best skills and knowledge is crucial.

  • Automating 40% of Clonakilty distillery processes and improving traceability
    30 Apr, 2024
    7 minute read

    Automating 40% of Clonakilty distillery processes and improving traceability

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    Tali Kauffmann
    Product Marketer at Opvia

    Clonakilty Distillery is a family-owned operation based on the scenic coast of Ireland. Founded in 2019 by the Scully family, it uses its unique maritime climate to produce distinctive whiskies and gins.

  • EBR system comparison: Top 5 solutions for 2024
    16 Apr, 2024
    13 minute read

    EBR system comparison: Top 5 solutions for 2024

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    William Moss
    CEO at Opvia

    Manufacturers looking to adopt electronic batch records (EBR systems) often find decision-making difficult. Pinpointing exactly what features will best serve their organisation isn't always easy.

  • How to improve your EBR workflow - step by step
    09 Apr, 2024
    19 minute read

    How to improve your EBR workflow - step by step

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    Tali Kauffmann
    Product Marketer at Opvia

    Many manufacturers who have already implemented an Electronic Batch Record (EBR) system may believe they're well-on the path to digitisation and greater efficiency.

  • How to transition from a laboratory notebook to an ELN
    26 Mar, 2024
    14 minute read

    How to transition from a laboratory notebook to an ELN

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    Thomas Owen
    Pharmaceuticals at Opvia

    For labs looking to make the jump from laboratory notebooks to electronic laboratory notebooks (ELN), it can seem like quite a big change. Increasingly, it's becoming the norm to digitise lab records and procedures.

  • What is a batch manufacturing record? A brief overview
    20 Mar, 2024
    9 minute read

    What is a batch manufacturing record? A brief overview

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    William Moss
    CEO at Opvia

    Batch manufacturing records (BMRs) are detailed documents that track every step of making a product in manufacturing plants. These files include what materials are used, the unique ID for each product batch, how long each part of the process takes, and the checks done to ensure the product is made correctly.

  • What is an electronic quality management system (eQMS)?
    19 Mar, 2024
    14 minute read

    What is an electronic quality management system (eQMS)?

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    Thomas Owen
    Pharmaceuticals at Opvia

    An electronic quality management system (eQMS) digitises how quality control is managed. It replaces paper-based systems with digital systems, integrating record-keeping, workflow automation, and quality checks into one platform.

  • Ingenza selects Opvia as its QMS provider to elevate biotech innovations
    18 Mar, 2024
    3 minute read

    Ingenza selects Opvia as its QMS provider to elevate biotech innovations

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    Tali Kauffmann
    Product Marketer at Opvia

    Edinburgh, Scotland – Ingenza, a dynamic CDMO and leader in engineering biology, is pleased to announce its strategic partnership with Opvia, a Quality Management Systems (QMS) provider.

  • MiAlgae Selects Opvia as Its Trusted Partner for EBR, ELN, and QMS Solutions
    21 Feb, 2024
    3 minute read

    MiAlgae Selects Opvia as Its Trusted Partner for EBR, ELN, and QMS Solutions

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    Tali Kauffmann
    Product Marketer at Opvia

    Edinburgh, Scotland - MiAlgae, a trailblazer in sustainable microalgae production for pet food and aquaculture feed, has chosen Opvia as its provider for Electronic Batch Records (EBR), Electronic Lab Notebook (ELN), and Quality Management System (QMS) solutions.

  • Bioomix selects Opvia as its ELN Provider to Accelerate Biotech Innovations
    09 Feb, 2024
    3 minute read

    Bioomix selects Opvia as its ELN Provider to Accelerate Biotech Innovations

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    Tali Kauffmann
    Product Marketer at Opvia

    Odense, Denmark – Bioomix, a Danish biotech company specialising in microbial bio-solutions, has chosen Opvia as its Electronic Lab Notebook (ELN) and data management system provider.

  • ERP VS MES - What do they mean and what are their differences?
    29 Jan, 2024
    9 minute read

    ERP VS MES - What do they mean and what are their differences?

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    Rachel Lim
    CDMO/CROs at Opvia

    There are various abbreviations that are often thrown around in the process development and manufacturing landscape. You may have heard of ERP and MES - but what do they actually refer to? As the name suggests, Enterprise Resource Planning (ERP) is a tool that supports the planning of resources within an organisation - this usually covers the 4Ms as follows: - Manpower: apart from human resources, this also includes the skills, technology, and organisational resources - Machine: often refers to equipment and instruments, but can also include hardware or apparatus unique to specific manufacturing industries.

  • Key Features to look for in an ELN
    16 Jan, 2024
    10 minute read

    Key Features to look for in an ELN

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    Bridget Withers
    Founder Associate at Opvia

    As labs continue to modernise and pivot from traditional to digital record-keeping, Electronic Laboratory Notebooks (ELNs) stand out as key tools in this transformation.

  • Why Every Modern Lab needs an Electronic Lab Notebook
    10 Jan, 2024
    9 minute read

    Why Every Modern Lab needs an Electronic Lab Notebook

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    Tali Kauffmann
    Product Marketer at Opvia

    An Electronic Lab Notebook (ELN) is a digital platform designed to replace traditional paper lab notebooks. It serves as a tool for scientists and researchers to record and store experimental data, observations, and results in an electronic format.  Gone are the days of bulky, coffee-stained paper notebooks brimming with hand-written notes.

  • A 7-Step Guide to Building a FAIR and Regulatory-Compliant Ontology: Mobilizing Data for Bioprocess Excellence
    14 Oct, 2023
    21 minute read

    A 7-Step Guide to Building a FAIR and Regulatory-Compliant Ontology: Mobilizing Data for Bioprocess Excellence

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    William Moss
    CEO at Opvia

    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.

  • 5 Tips to Implement a Quality Management System
    10 Oct, 2023
    7 minute read

    5 Tips to Implement a Quality Management System

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What is a QMS and why should you use one?
    10 Oct, 2023
    4 minute read

    What is a QMS and why should you use one?

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    Luke Jenema
    Business Development Manager at Opvia

    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”.

  • Unlock the Potential of Quality Management Systems
    6 Oct, 2023
    5 minute read

    Unlock the Potential of Quality Management Systems

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How electronic batch records facilitate the implementation of AI techniques
    3 Oct, 2023
    4 minute read

    How electronic batch records facilitate the implementation of AI techniques

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Avoid These 5 Common Pitfalls When Implementing Electronic Document Management in Food and Beverage Manufacturing
    02 Oct, 2023
    4 minute read

    Avoid These 5 Common Pitfalls When Implementing Electronic Document Management in Food and Beverage Manufacturing

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Why should you switch to electronic batch records?
    01 Oct, 2023
    7 minute read

    Why should you switch to electronic batch records?

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    Rachel Lim
    CDMO/CROs at Opvia

    In a manufacturing landscape characterized by stringent regulations, quality control, and the ever-pressing need for efficiency, accurate documentation and data management are paramount.

  • How an electronic batch recording system helps with CAPA planning
    14 Sep, 2023
    2 minute read

    How an electronic batch recording system helps with CAPA planning

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Documenting Success: Crucial Forms for Regulatory Adherence in Canada's Cannabis Sector
    13 Sep, 2023
    4 minute read

    Documenting Success: Crucial Forms for Regulatory Adherence in Canada's Cannabis Sector

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    Alberto Frias Fernandez
    F&B Expert at Opvia

    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.

  • What are the EU regulations to comply with for EBRs?
    2 Sep, 2023
    5 minute read

    What are the EU regulations to comply with for EBRs?

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Top 5 benefits of electronic batch records
    01 Sep, 2023
    5 minute read

    Top 5 benefits of electronic batch records

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • The Crucial Role of Document Management Systems in Empowering Social Enterprises
    28 Aug, 2023
    4 minute read

    The Crucial Role of Document Management Systems in Empowering Social Enterprises

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    Alberto Frias Fernandez
    F&B Expert at Opvia

    In the realm of social enterprises where the pursuit of social impact intertwines with business sustainability, the significance of streamlined operations cannot be overstated.

  • How an electronic batch recording software can help with DES models
    14 Aug, 2023
    2 minute read

    How an electronic batch recording software can help with DES models

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • The Essential KPIs to Automate from Your EBR – Transform the Quality and Efficiency of Your Manufacturing
    08 Aug, 2023
    10 minute read

    The Essential KPIs to Automate from Your EBR – Transform the Quality and Efficiency of Your Manufacturing

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • The API development process and how an EBR can help
    3 Aug, 2023
    4 minute read

    The API development process and how an EBR can help

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    Rachel Lim
    CDMO/CROs at Opvia

    When it comes to developing active pharmaceutical ingredients (APIs), efficiency and reliability are key. That's where an electronic batch record comes in.

  • Driving Progress in Plastics Research: Enhancing Efficiency and Innovation
    13 Jul, 2023
    4 minute read

    Driving Progress in Plastics Research: Enhancing Efficiency and Innovation

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    Thomas Owen
    Pharmaceuticals at Opvia

    In the ever-evolving field of plastics and compounding, researchers face the challenge of developing new materials with improved performance, sustainability, and cost-effectiveness.

  • How to Implement Electronic Batch Records in a Brewery: An In-Depth Guide
    03 July, 2023
    7 minute read

    How to Implement Electronic Batch Records in a Brewery: An In-Depth Guide

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Advancing Cosmetics Research: Accelerating Innovation and Sustainability
    30 Jun, 2023
    4 minute read

    Advancing Cosmetics Research: Accelerating Innovation and Sustainability

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • What to look for in a Scientific Data Management System (SDMS)
    16 Jun, 2023
    5 minute read

    What to look for in a Scientific Data Management System (SDMS)

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What to look for in an electronic batch record system?
    06 Jun, 2023
    3 minute read

    What to look for in an electronic batch record system?

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Top 3 pain points of a manufacturing process in the bioprocessing industry and how an EBR can help
    02 Jun, 2023
    4 minute read

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

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Best Practices for a perfect EBR for CDMOs
    30 May, 2023
    3 minute read

    Best Practices for a perfect EBR for CDMOs

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • 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?
    28 May, 2023
    7 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?

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Cell Therapy Manufacturing
    25 May, 2023
    2 minute read

    Cell Therapy Manufacturing

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Determining EC50s
    25 May, 2023
    2 minute read

    Determining EC50s

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • EC50 v LogP
    25 May, 2023
    4 minute read

    EC50 v LogP

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Endocrine In Vivo Studies
    25 May, 2023
    1 minute read

    Endocrine In Vivo Studies

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What are the FDA regulations to comply with for EBRs?
    20 May, 2023
    13 minute read

    What are the FDA regulations to comply with for EBRs?

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Ensuring Optimal Data Integrity in Electronic Batch Records: A Comprehensive Guide
    20 May, 2023
    30 minute read

    Ensuring Optimal Data Integrity in Electronic Batch Records: A Comprehensive Guide

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • How can an EBR help with the implementation of industry 4.0 aims?
    17 May, 2023
    6 minute read

    How can an EBR help with the implementation of industry 4.0 aims?

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Streamlining the batch record process with EBRs: a how-to guide for biotech companies
    09 May, 2023
    3 minute read

    Streamlining the batch record process with EBRs: a how-to guide for biotech companies

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How can electronic batch records enable you to achieve pharma 4.0 objectives?
    07 May, 2023
    2 minute read

    How can electronic batch records enable you to achieve pharma 4.0 objectives?

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What are the benefits of an electronic batch record system for cell-based foods?
    06 May, 2023
    9 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • 3 ways an electronic batch recording system can improve manufacturing yield
    03 May, 2023
    3 minute read

    3 ways an electronic batch recording system can improve manufacturing yield

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What are EBR best practices for validation and implementation?
    02 May, 2023
    2 minute read

    What are EBR best practices for validation and implementation?

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How can automated data collection help create digital twins for bioprocesses?
    28 Feb, 2023
    3 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How can automating sample management increase a CRO's throughput?
    28 Feb, 2023
    4 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How should you implement a CAPA plan for your manufacturing process?
    28 Feb, 2023
    5 minute read

    How should you implement a CAPA plan for your manufacturing process?

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Top 3 tips for efficient lab inventory management for bioprocessing companies using an automated inventory and resource management system
    27 Feb, 2023
    3 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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 Lab-Grown Revolution: Redefining the Future of Materials
    26 Feb, 2023
    8 minute read

    The Lab-Grown Revolution: Redefining the Future of Materials

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Using a PLM system to lower batch failures in bioprocessing
    24 Feb, 2023
    3 minute read

    Using a PLM system to lower batch failures in bioprocessing

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • Using PLM to bring medical devices faster to market
    24 Feb, 2023
    3 minute read

    Using PLM to bring medical devices faster to market

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What does using an EBR system in the biopharma industry look like?
    22 Feb, 2023
    4 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What is automated sampling and what are its benefits to the bioprocessing industry?
    21 Feb, 2023
    4 minute read

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

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • How does an EBR help with faster batch record reviews in the pharmaceutical industry?
    20 Feb, 2023
    3 minute read

    How does an EBR help with faster batch record reviews in the pharmaceutical industry?

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    Rachel Lim
    CDMO/CROs at Opvia

    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.

  • Why should process manufacturers consider an electronic batch record (EBR) system?
    20 Feb, 2023
    8 minute read

    Why should process manufacturers consider an electronic batch record (EBR) system?

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    Thomas Owen
    Pharmaceuticals at Opvia

    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.

  • What's the difference between an electronic batch record and a medical device history record?
    14 Jan, 2023
    4 minute read

    What's the difference between an electronic batch record and a medical device history record?

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    Rachel Lim
    CDMO/CROs at Opvia

    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).

  • Benefits of using an EBR in the food and beverage industry
    11 Oct, 2022
    3 minute read

    Benefits of using an EBR in the food and beverage industry

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    Alberto Frias Fernandez
    F&B Expert at Opvia

    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.

  • Unleash the Power of Automations: 10 Spectacular Biotech Visualisations You Can Build With Opvia
    11 Oct, 2022
    5 minute read

    Unleash the Power of Automations: 10 Spectacular Biotech Visualisations You Can Build With Opvia

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    Rachel Lim
    CDMO/CROs at 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.

  • Optimising inventory planning through a product lifecycle management (PLM) system
    07 Oct, 2022
    4 minute read

    Optimising inventory planning through a product lifecycle management (PLM) system

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    Alberto Frias Fernandez
    F&B Expert at Opvia

    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.

  • From data collection to insights - How automated data systems can improve manufacturing
    4 Oct, 2022
    4 minute read

    From data collection to insights - How automated data systems can improve manufacturing

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    Alberto Frias Fernandez
    F&B Expert at Opvia

    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.