The importance of GAMP 5, a pragmatic approach to computer systems validation


I have now been involved with GAMP COP since the late 90’s and have benefited from using the consistent GAMP Lifecycle approach that is recognized now globally for use in aiding the approach that organizations use in the validation of Computerized Systems, ensuring that software is fit for its intended use, prior to acceptance by the business.

The following paragraphs outline what GAMP continues to aim for.

• Pragmatic interpretation of regulatory requirements:
The ISPE has a regulatory representative that enable the Community of Practices (COP) such as GAMP to glean useful regulatory direction. As well as this, we have Reviewers from various Global Regulatory agencies, such as FDA, MHRA, EMA, etc. This enables the ability to produce Guidance that has adapted to the Best Practice needs globally, as well as understanding changes in the Technological and Innovation needs.

• Identification and definition of real-world good practice:
The GAMP COP have built guidance in recent years based on international standards and guidelines such as, ASTM, ICH, PICS. WHO. ISA, ISO, MESA and SCOR, to name but a few. For a full list of references, see Appendix G3, A Risk-Based Approach to Compliant GxP Computerized Systems.

• Support for new and innovative technologies:
GAMP 5 has recently been enhanced by the completion of the ISPE GAMP® Good Practice Guide – Enabling Innovation. Although not prescriptive the guide recommends scaling all life cycle activities and associated documentation according to risk, complexity, and novelty. Acknowledging that traditional linear or waterfall development models are not the most appropriate in all cases. We now have also introduced Agile development.

It is important to note that based on the requirements of the software provider or the user company implementing the software, the different methodologies may streamline the project and the phases, but one cannot get away from producing an initial business case, with high level objectives and requirements, that should be understood by all stakeholders.

GAMP 5 is recognized as the leading industry guidance on computer systems compliance with:

• Very significant regulatory input
• A common international framework
• Available in several languages

We can now look forwards to the Second Edition which should be available for purchase from August on-wards from the ISPE website. I am so pleased to be a part of the Global team working on updated content as a volunteer. You get a lot of satisfaction when the finished article has gone through final edit and is available to the Life Sciences Industry.
On a final note, being part of the GAMP Community Of Practice enables our team at Northern Life Sciences (NLS) stay ahead of the game, advising prior to guidance being publishing, thoroughly understanding all the models and tools and being able to apply pragmatic solutions to help organizations stay inspection ready with their Computerized Systems.