GAMP 5 French Translation -- Table of Contents


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WebGAMP 5 Page 9 Une approche de la conformité des systèmes informatisés BPx basée sur les

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WebGAMP 5 -- Table of Contents Author: ISPE Created Date:

  • What is a gamp document?

    GAMP documents are guides and not standards. It is the responsibility of regulated companies to establish policiesand procedures to meet applicable regulatory requirements. Consequently, it is inappropriate for suppliers orproducts to claim that they are GAMP certified, approved, or compliant.

  • What is Gamp® 5?

    GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (First Edition) A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) A Risk-Based Approach to GxP Process Control Systems (GPCS) (Second Edition) A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS) (First Edition)

  • What is the ISPE GAMP community of practice?

    The ISPE GAMP Community of Practice (CoP) performs regular ongoing assessments and reviews of GAMP knowledge against current practices and regulatory and technology developments. ISPE GAMP 5 Second Edition therefore embraces and reflects:

  • Where can I find a gamp® Good Practice Guide?

    GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) Please visit the ISPE Japan Affiliate website or contact ispe-admi@ispe.gr.jp for more details or to order these guides. Biopharmaceutical Manufacturing Facilities (Second Edition)

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