Tag Archive for Martin Browning

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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