Q: I’ve been assigned to do a product risk assessment on a new device we’re developing. My background is not in risk management, so any advice you can offer would be very much appreciated. I’m especially concerned about how often we…
Tag Archive for Design control
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
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Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
Design Validation: More than Just User Testing
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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…
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…
Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches
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Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days? A: Supplier management — how carefully…
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 —…
CAPA Data Sources; What Makes a Compliant CAPA System
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Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? Moreover, what are…
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…