Q: Are our quality risk management findings accessible to regulatory agencies? Or are they considered private and confidential company information? A: All quality risk management activities and documentation are accessible to the regulatory authorities. Your company should base its findings on the…
Tag Archive for Design control
Connect Your Quality Subsystems with Data Links to Strengthen Quality Compliance
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Q: In one of your training classes, you mentioned the importance of establishing data linkages between the various quality subsystems of our overall Quality System. Can you explain further and provide some examples? A: FDA believes these four quality subsystems should be…
Quality System Maintenance: What Activities Does FDA Expect to See?
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Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product. Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a…
Product Risk Assessment Basics: Continually Collect Data, Update Documentation Often
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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…
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…