Tag Archive for software

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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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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