Tag Archive for Annex 11

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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