In the summer of 2022, the second edition of the GAMP 5 of the ISPE was released, Evalu presents you the main lines.
What is GAMP 5?
GAMP 5, released in 2008, is not a regulatory text, but a best practice guide to meet regulations concerning the validation, design and development of computerized and automated systems. Version 5 of GAMP takes a fresh look at user/supplier relationships and qualifications, as well as the notion of risk analysis.
In the second version of the guide, the importance of critical thinking is emphasized. In addition, this edition remains patient-focused and promotes innovation while remaining compliant with regulations, all in a pragmatic manner.
GAMP Challenges 5 Ed 2 :
- Supporting innovation with the objective of ensuring product and patient safety and data integrity
- Save time and have less rigid and more efficient approaches (importance of critical thinking)
Topics addressed by GAMP 5 Ed 2 :
Importance of service providers, including encouraging regulated companies to maximize provider participation to leverage knowledge, experience and documentation to the extent possible.
Consideration of agile software development methodologies, emphasizing that the GAMP specification and verification approach is not inherently linear but perhaps incremental.
Use of automation tools to achieve better control, better quality and shorter lead times throughout the project.
Taking into account new technologies such as blockchain, openchain, …
Propose an approach that can also meet other requirements including Sarbanes-Oxley for finance and RGPD for personal data.
