Tag Archive for Validation

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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