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The draft revision of EU GMP Annex 11 goes from about five pages to nineteen. It isn't final yet, but most of what it asks for lands in SOPs you already own.
Read articleMost startups need a quality system earlier than they planned. When the obligation starts, what to set up first, and what to check before you pick one. …
CSA is final, it has already been reissued for the QMSR, and it gets misread a lot. What it asks for, who it formally applies to, and how it compares with EU expectations. …
ICH E6(R3) raises a practical question for clinical teams: is compliance built into trial execution, or reconstructed after the fact? …
A useful gap analysis says where you are covered, where you are partial, and where you are exposed, instead of listing documents that look related. …
Regulated contexts require explainable AI: a team has to be able to trace an output back, review it, and get the same result again. …
