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... 
by andrew | Feb 18, 2022 | Marketing
In the world of Good Manufacturing Practices (GMP), compliance is more than just ticking boxes. However, it is about safeguarding quality, ensuring patient safety, and driving operational excellence. At Truex Consultancy, we understand this completely. Moreover, what... 
by andrew | Feb 18, 2022 | Business
“It’s just another piece of paperwork, isn’t it?” This familiar refrain echoes through manufacturing facilities worldwide when teams encounter yet another Standard Operating Procedure, compliance form, or audit corrective action. At Truex... 
by andrew | Feb 18, 2022 | Marketing
Is Your Company Truly Ready for the Next GMP Audit? GMP audit readiness is critical before your next regulatory inspection. In our last post, we highlighted the power of a GMP Quality Mindset as your strongest defense. The real question is: how do you quantify that... 
by Gregory Sivo | Feb 18, 2022 | Marketing
Have you ever felt the palpable tension in the air when Quality Assurance (QA) steps onto the production floor? It’s a classic corporate friction: Operations is driven by speed, while QA is driven by compliance. If you’ve ever found yourself caught in the middle of...