Tag Archive for records

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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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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