qmsdoc.com is operated by eCompliance Ltd., a Tokyo-based regulatory consulting firm. We provide editable Microsoft Word QMS document templates for medical device and pharmaceutical companies seeking FDA, GMP, and Part 11 compliance. Curated by Koichi Murayama — 30+ years of FDA QSR/QMSR & CSV/Part 11 experience.

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Birth of the Validation Concept

Purpose of PQ

バリデーションの概念の誕生

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 対訳版

What is a Qualification Assessment?

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS　ANNEX 15　対訳版