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Full Description

The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practices, linking traditional terminology and approaches to the newer science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for organizations with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.
 

Document History

  1. ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition


    ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition

    • Most Recent
  2. ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

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    ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

    • Historical Version
  3. ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment


    ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

    • Historical Version
  4. ISPE Baseline Guide: Volume 5 - Commissioning and Qualification


    ISPE Baseline Guide: Volume 5 - Commissioning and Qualification

    • Historical Version