Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…
Tag Archive for Testing
Are Off-the-Shelf Coding Tools Subject to GxP Regulations and Inspections?
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Q: As you know, off-the-shelf coding tools are used during various stages of software development. Among them are some tools used to manage quality standards as defined in the organization QMS. An example would be SonarQube, used to manage code…
Windows 10 Validation: How to Handle Validation of Monthly Patches/Updates
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Q: I have a question about Windows 10 validation. In your FDA Auditing of Computerized Systems and Part 11 /Annex 11 class, you pointed out that the “environment” for software/hardware is important when it comes to validation, because a different environment…
Can You Trust E-Signatures from Your Software Package Vendor?
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Q: I have concerns about e-signatures supplied by a software vendor. Our company is using a Quality Management System (QMS) supplied by a software vendor who provides a validation package. The package shows how the QMS was validated, and the documents…
Determining What’s “Production Equivalent” with a New Product Design
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Q: I’m dealing with a design contract house responsible for product design of a medical device. They are responsible for all of the documentation needed for design control, etc. If we produce the first 100 units via the contract house, those units will be…
SOUP: FDA’s Recipe for Open Source Software
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Q: Is it acceptable by FDA to use open source software for low critical applications? These applications do not have a direct impact on patient safety but are used to support GxP activities. An example would be a software testing tool.…
Regulated Software and Systems: What FDA Expects to See
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For the regulated software and systems you use in your activities, consult this list — prepared by former FDA investigators at EduQuest (including EduQuest President Martin Browning, the co-author of Part 11) who have done thousands of computer system audits worldwide —…
GAMP5 Definitions: Assigning Categories for Software Validation and Documentation
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Q: Under GAMP5 definitions, I’ve found that assigning a category to a software product is a bit confusing — particularly distinguishing between Category 3 and 4. My understanding is that Category 3 software allows the user to make selections (configure) the…
Can Characterization Substitute for Design Verification?
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Q: We have characterized a material change to our medical device and have confirmed there’s no impact to any of our design inputs or outputs. Do we still have to formally perform Verification and Validation (V&V)? In other words, is the…
Design Change: How Does FDA Define It?
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Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…