QA/RA Consulting, Auditing & Training
EUDAMED Is Live – and It’s Mandatory For years, EUDAMED was the regulatory equivalent of “coming soon.” Now that it’s here, it is operational for medical device and IVD companies that are marketing products in the EU and, for many companies, it is no longer a future project. It is now a part of a […]
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Are You Solving the Problem—or Just Closing the Deviation? If you’ve worked in pharma long enough, you’ve seen this play out. A deviation gets raised, maybe a parameter drifts during a batch, or an environmental monitoring trend doesn’t look quite right, or a result comes back out of specification. An investigation starts. People ask the […]
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Why Experience Alone Isn’t Enough in Aseptic Processing The longer a process runs without issue, the easier it becomes to assume everything is under control. That’s exactly when organizations need to pay attention. In a previous blog, we explored how aseptic processing depends on the alignment of systems, environments, and people. Procedures matter. Controlled environments […]
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Aseptic Processing Isn’t Just a Procedure, It’s Where Control Is Won or Lost Small gaps don’t stay small in sterile manufacturing. The real risk isn’t missing controls—it’s assuming they’re working as consistently as you think. In sterile manufacturing, there’s no such thing as a small mistake—only small signals that get missed until they become major […]
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GLP Auditing in a Global Context: What OECD Adds Beyond 21 CFR Part 58 and Why ISO 19011:2026 Matters The real test of a GLP audit is not whether it finds signatures missing from records or an outdated procedure – it’s whether the organization can answer a far more uncomfortable question five minutes before an […]
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Why FDA Inspections Feel Different Now: Part II – SaMD, IEC 62304, and AI Enabled Devices In Part I, we explored why FDA inspections feel different under QMSR: inspectors are following risk, connecting information across the product lifecycle, and evaluating how quality systems actually function in practice. For software-driven products, those same shifts are even more […]
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