Field notes: data scientists discovering chemometrics
Synthesised observations from PAT-adjacent engagements where data scientists from web-product backgrounds collide with chemometricians steeped in PLS, ASTM E1655, and calibration transfer.
Tag
#validation
7 articles tagged validation.
How to evaluate vendor proposals for inline analyzers
A structured approach to RFP evaluation for inline process analyzers, covering specification verification, calibration transfer, validation evidence, FAT/SAT scope, and lifecycle maintenance burden.
Field notes: validation engineers and the PAT lifecycle
A composite of conversations with validation engineers working on pharmaceutical and biopharmaceutical PAT installations. The hardest parts of the job sit at the seams between project, quality, and operations.
Calibration transfer between instruments: a working protocol
A partial least squares model rarely survives the move to a second instrument unchanged. A working protocol covers transfer set design, the standardisation method, and the acceptance criteria.
Peer-reviewed PAT validation work, late 2025 to spring 2026
Six recent peer-reviewed PAT papers worth a read: lean chemometrics for spectroscopic models, simpler bioprocess Raman regressions, at-line terahertz for crystallinity, and PAT-with-machine-learning past the bioreactor.
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.
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.