Q: We recently audited a prominent Electronic Data Capture (EDC) software vendor. We were discouraged to learn they’ve restructured their QA group such that the QA oversight role is greatly diminished. For example, the vendor no longer schedules annual internal audits…
Tag Archive for Audit
Supplier Evaluations and Audits: Roles, Requirements and Limitations
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Q: Could you explain the difference between supplier audits and a supplier evaluations? As I recall from attending your training classes, you’re a proponent of evaluations. Could you explain further? A: It’s not so much that I’m a proponent of supplier evaluations…
Quality System Maintenance: What Activities Does FDA Expect to See?
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Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product. Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a…
FDA’s Perspective on Quality Agreements between Sister Sites
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Q: What is FDA’s perspective on contracts or quality agreements with sister sites — sites owned or operated by the same parent company — that supply the primary manufacturer with materials or components? When using a sister site as a…
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches
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Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days? A: Supplier management — how carefully…
ER Analogy: When to See the CAPA “Specialist”
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Q: My company continues to struggle with deciding when to elevate a complaint to the level of a CAPA. And at times we disagree about how to differentiate complaints, non-conformances, and CAPAs. Can you help us sort it all out? A:…
CAPA Data Sources; What Makes a Compliant CAPA System
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Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? Moreover, what are…
Internal Audits: Are They Really Necessary?
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Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…
Re-Audits: When and Why Should You Conduct Them?
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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…