Tag Archive for Change Control

Design Change: How Does FDA Define It?

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…

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Audit Trail Corruption: How to Correct and Document It

Q: We’re a laboratory software developer. Recently, while examining a customer’s data, we discovered some corruption in their audit trail data — a few duplicate records. We’re tracking down how this happened, and of course we will correct the root cause. However, my question…

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Management Reviews: A Checklist for Compliance

An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…

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Internal Quality Audits: What to Target

Q: With your experience as an FDA investigator and independent auditor, can you advise me on some specific things to look for when I’m conducting internal quality audits? A: First, make sure all your required Quality System procedures are defined,…

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