各種ガイダンス

お役立ち翻訳, 各種ガイダンス

General Principles of Software Validation （pdf版）

ecompliance / February 11, 2019

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FDA, 各種ガイダンス

Guidance for Industry Process Validation: General Principles and Practices (2011.1)

ecompliance / December 23, 2018

Guidance for Industry Process Validation: General Principles and Practices (2011.1) ]]>

FDA, 各種ガイダンス

Guidance for Industry, Third Parties and Food and Drug Administration Staff – Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program （FDA 20123.19）

ecompliance / June 24, 2018

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