GAMP® 5 Second Edition

The Computerized System Validation community has just celebrated the 30th anniversary of the ISPE GAMP® Guide and now we are excited about the release of GAMP® 5 (Second Edition) in August 2022.

The ISPE GAMP® 5 Guide is considered the definitive guide to GxP compliance and computerized systems validation for companies and suppliers, and is referenced by regulatory agencies around the world. It provides a pragmatic and practical guide for industry to achieve compliant computerized systems suitable for their intended use in an efficient and effective manner. The flexible, risk-based approach to GxP-compliant computerized systems, based on scalable specification and verification, has proven effective for all types of systems, no matter how large or small.

This edition retains the principles and framework of the First Edition, but has been updated and expanded to reflect the increasing importance of service providers, changing approaches to software development, and the widespread use of cloud technology, software tools, and automation. It emphasizes the need for critical thinking by knowledgeable and experienced experts to define appropriate approaches.

We are honored and proud to have been part of the GAMP® 5 (Second Edition) Core Team and to have contributed to the creation and review of the guide. QFINITY has been an active contributor within the ISPE GAMP community for many years and has contributed to ISPE Good Practice Guides such as “Enabling Innovation” and “Validation and Compliance of Computerized GCP Systems and Data”. Now we add GAMP® 5 (Second Edition) to this list.

QFINITY was part of the GAMP 5 (Second Edition) presentations at the ISPE Annual Meeting (2022) in Orlando and will be at the EU Annual Meeting 2023 in Amsterdam. We look forward to meeting you there.

However, if you have an urgent need for QFINITY’s expertise and services, please contact us.

QFINITY is proud to have contributed to GAMP® 5 (Second Edition)!

Highlights of the GAMP® 5 (Second Edition) are:

  • Validation

    of systems with artificial intelligence and machine learning.

  • Agile

    Agile software development

  • IT Service Management

    including cloud solutions (incl. SaaS validation)

GAMP® 5 Second Edition