Guidance for the Content of Premarket Submissions for Software Contained…
electronic or paper depending on whether electronic or paper is right
General Principles of Software Validation （pdf版）
Annex 15: Qualification and Validation（邦訳）
Quality Systems Approach to Pharmaceutical CGMP Regulations（2006.9）
サイトマスターファイル 製薬協・APAC（Asia Partnership Conference of Pharmaceutical Associations）での課題としてアジア規制当局、業界団体も調整して作成
Guidance for Industry Process Validation: General Principles and Practices (2011.1)
What is a Qualification Assessment?