Compliance
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. …
Compliance
Most 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. …
Compliance
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. …
Compliance
ICH E6(R3) raises a practical question for clinical teams: is compliance built into trial execution, or reconstructed after the fact? …
