Quality Systems

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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CAPA Data: What Can FDA Request to See?

Q: It’s my understanding that during an FDA audit of a pharmaceutical company, the Agency can request to see CAPA data from internal audits — but if you’re a medical device company, it can’t. Is that correct? Also, can the FDA request to see…

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