Role of GAMP 5 in computer system validation.

Few of the mostly used acronyms used by validation professionals in industry are URS (User requirement specification), IQ (Installation qualification, OQ (Operational qualification), PQ (Performance qualification), DQ (Design qualification), UAT (User acceptance testing) and GxP (Good X practice) and many buzz words like “Gap analysis, Computer system validation, Risk management and many more.

Industries like Pharmaceutical, FMCG, Food and Beverages have to comply with ever stricter legislation, including regulations of the European Medicine Agency (MEA) and Food & Drug Administration (FDA). But Good Automated Manufacturing Practices (GAMP) is not legislation, it is an important guideline for companies regarding computer system validation.
It is not mandatory to follow this methodology. GAMP 5 outlined a methodology for computer system validation that is generally accepted within industries. GAMP defines structured guideline for the validation of automated system and now version 5 is the current version for more risk and quality control. GAMP 5 helps the companies operating under legislative authorities to ensure the required quality and compliance. Companies can easily get green signal from FDA and government inspections.

The objective of computer system validation is to demonstrate the system functions as intended. Computer system validation can be successfully accomplished by using the requirements and specifications as an objective standard to which the system is tested. If the test passes, the executed test scripts serves as documented evidence that all the requirement and specification were met.

The guidelines not only apply for validation, but also for various processes within your organization as risk management, supplier relation, and system maintenance. Consequently, it is important to take a holistic approach to applying GAMP 5 by incorporating the principles in the relevant processes. Make sure that you are not blindly applying GAMP 5 methodology. Review carefully the GAMP methodologies with the help of subject matter experts to ensure that the recommended methodology is suitable for your system and organization.