Documentation

Incoming Inspection: Is Pass/Fail OK?

Q: At my company, incoming inspection includes measuring the length of a cable used in our products. The results are recorded as “pass/fail”. My colleague thinks the actual results (the measurement) should be recorded instead. I can’t recall an actual regulation…

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Part 11 Password Safeguards: What’s Really Required?

Q: My question concerns the requirement for Part 11 password safeguards (Part 11.300(d)) that prevent unauthorized use of passwords or identification codes. We’ve always considered the “detect and report” portion of this requirement to include logging unsuccessful attempts and then reviewing those…

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Internal Audits: Are They Really Necessary? 

Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…

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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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Re-Audits: When and Why Should You Conduct Them?

Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits? Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include? A: My experience is that industry rarely does what is…

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