Blog Home TAG: GMP Audit

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve [...]


How an EQMS can Reduce CAPA and Complaint Observation Trends

As we move through 2022, we look forward to new opportunities, new challenges, and a return to normal. Unfortunately, one thing that won’t change is the likelihood of FDA CAPA and complaint [...]


5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process

This article is part two of a two-part series focused on GMP quality audit management. The very concept of an audit puts auditors on one side and auditees on the opposite side. This is especially [...]

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