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... by Gregory Sivo | May 4, 2026 | General
Why Data Integrity Is the Dominant GMP Finding of 2026 If you are preparing for a regulatory inspection in 2026, there is one area above all others where preparation must be demonstrably robust: data integrity. Between 2016 and 2023, the FDA issued 1,766 Warning...