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Category: Posts

EU Annex 1 Compliance: Your Contamination Control Strategy

EU Annex 1 Compliance: Your Contamination Control Strategy...

October 5, 2026
Three years after the revised EU Annex 1 came into force, nearly every sterile manufacturer I talk w...
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How We Are Building Our SOC 2 Program Inside Our Own Software

How We Are Building Our SOC 2 Program Inside Our Own Softwar...

September 21, 2026
By Brandy Irons, Sr. Training Manager and Technical Support, InstantGMP Most software companies keep...
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InstantGMP Outlines AI Governance Approach for GxP Electronic Records Ahead of EU AI Act’s Delayed High-Risk Deadline

InstantGMP Outlines AI Governance Approach for GxP Electroni...

September 14, 2026
CARY, N.C., September 2026 – InstantGMP™ is an ISO 9001 certified manufacturing software  and G...
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Most Prevalent GMP Manufacturing Issues of the Past Year

Most Prevalent GMP Manufacturing Issues of the Past Year...

September 9, 2026
Guest article provided by BioBoston Consulting for InstantGMP There is no single regulatory database...
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InstantGMP™ Release Notes for Version 4.006.501...

August 24, 2026
InstantGMP Release notes for version 4.006.501 System Release Compliance Report for v4.006.501 New F...
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FDA’s 7-Step AI Credibility Framework, Decoded for GMP Manufacturing

FDA’s 7-Step AI Credibility Framework, Decoded for GMP...

August 11, 2026
The Regulatory Challenge Here’s the insight that took me a minute to actually appreciate, and I’...
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Annex 22 Excludes LLMs from Critical GMP Applications. Where Does That Leave Your Agentic AI?

Annex 22 Excludes LLMs from Critical GMP Applications. Where...

July 29, 2026
Recently, we have been giving demonstrations of our agentic AI MCP server that queries InstantGMP da...
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AI Took a Shortcut and the FDA Noticed. Here’s What Purolea’s Warning Letter Really Tells Us.

AI Took a Shortcut and the FDA Noticed. Here’s What Pu...

July 22, 2026
A few days ago I wrote about what nobody tells you about AI validation in GMP manufacturing (https:/...
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InstantGMP™ Release Notes for Version 4.006.401...

July 18, 2026
InstantGMP Release notes for version 4.006.401 System Release Compliance Report for v4.006.401 New F...
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AI in GMP Manufacturing: What Nobody Tells You About Validation

AI in GMP Manufacturing: What Nobody Tells You About Validat...

July 17, 2026
Everyone is talking about using AI in manufacturing, but almost nobody is talking about how to valid...
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