by Gregory Sivo | Jul 27, 2026 | Quality Systems
When an inspector wants to understand a site quickly, they do not start with the validation master plan. They ask for the deviation log, the full list, unfiltered, including everything still open, and they read the age profile before they read a single investigation.... by Gregory Sivo | May 31, 2026 | General
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read GMP audit preparation has a way of turning into a last-minute scramble. This article explains why that happens, what the scramble reveals about the underlying quality system, and how... by Gregory Sivo | May 25, 2026 | General
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read Learn what EU GMP and ICH Q10 require from a change control system, why change control programmes fail in practice, and what a compliant, inspection-ready process looks like from the inside. One... by Gregory Sivo | May 17, 2026 | Niet gecategoriseerd
Learn what GMP regulations require from management reviews, why they so often fail in practice, and what a compliant, inspection-ready review record looks like. One of the first questions we ask when we arrive at a regulated site is simple: when was your last... by Gregory Sivo | May 11, 2026 | Niet gecategoriseerd
By a GMP Compliance Specialist | Updated May 2026 | 12-minute read Regulatory agencies don’t stand still — and neither should your quality system. Whether you’re operating under EU GMP, FDA 21 CFR Part 211, or ICH Q10, one expectation runs through every...