Tag Archive for FDA

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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Validating an HR-Related System: What Would FDA Say? 

Q: We’re having an internal debate about validating an HR-related system. We understand FDA expects us to validate manufacturing or operational-related systems such as manufacturing execution systems (MES), laboratory information systems (LIMS), quality management systems (QMS), and learning management systems (LMS). But…

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Objective Evidence: How to Document It to FDA’s Satisfaction

Q: Could you tell me what’s considered best practice when it comes to documenting objective evidence? A: First of all, remember that objective evidence is NOT the words “pass/fail”, “true/false”, “as expected”, or “yes/no”. They are conclusions. [pullquote align=”right” cite=”” link=”” color=”” class=””…

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