Computerized System Validation (CSV) – GAMP 5 Second Edition

2nd Edition of the GAMP 5 Guideline will address required changes in computerized system validation (CSV). Have you adopted the changes yet?

The validation of computerized systems will become increasingly important due to the usage of Industry 4.0 in pharmaceutical and biotech industry, resulting in increasing number of digital process steps.

Since 2008, GAMP 5 has been the most important guide for the practical implementation of computer system validation (CSV) and thus represents an important aspect of GxP (GMP, GLP, GDP, etc.)-compliant qualification and validation. Since its publication, however, a large number of advances and changes have occurred in the field of computer-based systems; processes are, for example, increasingly being processed cloud-based. Regulations such as EU-GMP-Guideline Annex 11 have been revised. Thanks to the foresight of the creators, the concept of GAMP5 could be left unchanged to meet these requirements. Only little had to be changed in the basic principles. Therefore, the new version published at the end of July 2022 is called GAMP 5 Second Edition.

In the following chapters, we will present three changes and innovations as examples:

• One of the most noticeable changes is the merging of the user requirements and functional specification sections into the “specifying requirements” chapter. This adjustment considers the increased use of agile development and automated processes. New tools and automation for setting requirements are used to define them on the system, but there is also an increasing need for cooperation between suppliers and customers.
• The testing strategy in the various phases of the software life cycle has been adapted. The test strategy should be based on risk acceptance and a critical thinking approach, to which a separate appendix has been dedicated in the new edition. All phases of the life cycle of development, validation, production and application should be included in the test strategy. Control and monitoring should be defined in advance and by no means not be limited to classical testing based on protocols. Free testing, classically referred to as trying out can improve the detection of deviations and must be documented during execution. Automated testing helps to significantly accelerate repeatability, completeness and speed.
• A new appendix describes strategies for dealing with software tools. Although not directly applied in the GxP processes, they are used in various areas of the lifecycle such as development, but also for IT processes and IT infrastructure. Here, topics such as selection, risk consideration and lifecycle of the tools are discussed.

The examples presented here are only a small selection of the innovations, we would be happy to advise you regarding all new features.

Valicare GmbH (subsidiary of Syntegon Technology GmbH) has successfully implemented GAMP 5 for computer system validation in practice in a large number of projects. We have all the necessary documents and specifications to implement computer system validation based on the revised GAMP 5 for you as well.

For more information about our GMP-compliant computer system validation services, please visit our website.