The FDA released its current guidance on General Principles of Software Validation in 2002. But a lot has changed since then.

Which begs the question: Is your medical device company up to speed on the latest validation requirements and best practices?

In 2020, the FDA will be releasing new guidance called Computer Software Assurance for Manufacturing, Operations, and Quality System Software.

This new guidance was developed specifically for the medical device industry and will include guidelines for how to streamline documentation by improving critical thinking, patient and product safety, risk management processes, data integrity, and quality assurance.

The FDA’s guidance documentation will apply to research and development (R&D), laboratories, clinical environments, and other groups within the biopharmaceutical, pharmaceutical, and medical device fields. Keep reading for an overview of some of the top-line software validation requirements instituted by the FDA in 2020.

What are the Top FDA Software Validation Requirements?

Have you found your company scrambling to enable remote work thanks to COVID-19? Are you experiencing problems and delays with your supply chain or quality management issues due to broken processes?

In a recent webinar, our quality management experts at Qualio talked about some of the challenges life sciences companies such as yours are facing — and what you can do about it.

Watch the webinar now, or keep reading to learn more about the top FDA software validation requirements.

Understanding the Shift in Software Validation

In the past, the FDA placed a substantial emphasis on documentation to the point that companies found the regulations too burdensome when transitioning from paper-based methods to automation and technology.

Now, the FDA is flipping the script and releasing new guidelines that include a mindset shift from a documentation-first approach to a critical-thinking-first approach.

This change in approach means that they are encouraging medical device and life sciences companies to transition to computer software for quality management instead of relying on paper-based methods. That's because quality management software:

  • Gives companies better insight and product performance knowledge
  • Is easier to track and trend
  • Allows companies to respond in a more timely manner
  • Streamlines and optimizes processes
  • Provides better patient experiences
  • Reduces product risks
  • Reduces operational expenses
  • Increases the value of your business

With this shift in the FDA’s position on automation and technology, a change in validation practices is also essential. Some questions you need to ask yourself when shifting your validation practices include:

  • How does this impact patient safety?
  • How does this impact device quality?
  • How does this influence the quality system integrity?

When making the switch from a paper-based QMS to electronic Quality Management Software (eQMS), you'll need to ensure it complies with these FDA software validation requirements:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Keep the above questions in mind as we dive into what each of these requirements are and what it means when investing in an eQMS.

It’s also important to remember that simple “do-it-yourself” technology options like Microsoft Excel are not going to be sufficient to meet the FDA requirements. They don’t have the necessary tools — like audit trails or passwords for individual users — to be able to meet the electronic record requirements outlined in 21 CFR 11 or Annex 11. For the best results, you will need to use a quality management system that’s designed to meet these requirements.

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Installation Qualification (IQ)

According to the FDA, Installation Qualification (IQ) is defined as “establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer’s recommendations are suitably considered."

If your company is based in Europe, Annex 15 defines it as the “documented verification that the facilities, systems, and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.”

When validating your eQMS for IQ, you need to ensure that:

  • It’s installed correctly and configured correctly according to the standards set by the software developer or an approved installation checklist.
  • Computer-controlled instrumentation is documented correctly.
  • All the peripherals are connected and working correctly.

Operational Qualification (OQ)

Operational Qualification (OQ) is defined by the FDA as “establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances.”

According to Annex 15, it’s the “documented verification that the facilities, systems, and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.”

When assessing your eQMS for OQ, you to make sure that:

  • The software has been tested and performs as expected.
  • Al testing of the software and the results are documented.
  • Each screen accepts the right data for that step.
  • An item can be moved throughout your entire workflow.
  • All technological controls are compliant with 21 CFR 11 and function as expected.

Performance Qualification (PQ)

As defined by the FDA, Performance Qualification (PQ) is “establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.”

According to Annex 15, it’s defined as the “documented verification that the facilities, systems, and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.”

Validating your eQMS for PQ involves:

  • Verifying and documenting that all equipment and the software is working as expected under real working conditions.
  • The results generated are reproducible.

Are You in the Market for a New eQMS?

Qualio is an eQMS that was created specifically for medical device and life sciences like yours. We stay on top of the latest regulations that impact your industry and make sure that our eQMS system is built to make staying in compliance easy.

Learn more about Qualio and how it can help you gain a competitive advantage and maintain FDA compliance by requesting your free demo.

“The user interface for this program is great, it’s all-round easiest to use (much more so than other eQMS systems I’ve used). I love that it’s web-based which is great when you’re working from home. It’s simple to navigate the program and creating, reviewing and approving documents is relatively painless.” — Theo S., QC Microbiology Supervisor

Is an eQMS becoming a necessity for your company in the COVID-19 era?

Watch our free webinar to learn how you can maintain and improve your quality management system while working remotely.

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Published by Robert Fenton September 1, 2020
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