Tag Archive for Part 11

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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Audit Trail Corruption: How to Correct and Document It

Q: We’re a laboratory software developer. Recently, while examining a customer’s data, we discovered some corruption in their audit trail data — a few duplicate records. We’re tracking down how this happened, and of course we will correct the root cause. However, my question…

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FDA’s Expectations for Software Traceability

Q: It’s my understanding that FDA standards and guidelines call for software traceability of the requirements down to the level of the code (modules and functions). However, I believe a lot of companies may not be able to demonstrate requirements traceability down to…

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