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.
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2 articles tagged validation.
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.
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.