Tag

#validation

2 articles tagged validation.

Validating a chemometric model for GMP: a working checklist

ICH Q14 sets the framework. ASTM E1655 sets the practice. The intersection - what an inspector actually wants to see in a chemometric validation file - is a short, specific list.

Dr. Friederike Hentschel Apr 23, 2026

Writing a PAT user requirement specification

guide

How to write a PAT user requirement specification

A user requirement specification is the contract between the process owner and everyone else. Done well it shrinks the project; done badly it bloats it. The structure that survives audit and procurement.

Jeroen van der Linden Apr 22, 2026