GAMP V computer system validation

GAMP – Founded in 1991, Good Automated Production Practices is a trademark of the International Society of Pharmaceutical Engineering (ISPE). GAMP-V was introduced in 2008 and provided a series of procedures to help ensure that automation equipment/software meets the quality requirements necessary.

'Quality with design' is one of GAMP's fundamental values and encourages quality in all phases of the development cycle.

GAMP is a Guideline Not a Regulation.

When adhering to GAMP, customers in the medical device, pharmaceutical, and life sciences industries are assured that their machines are designed and constructed under a Total Quality Management System. A systematic method of comprehensive reporting, checking, and logical analysis, which validates customer requirements. The cycle starts with a specification for the user's specifications for the system that provides a practical requirement and design specification. Such documents then form the basis for an internal acceptance traceability matrix for formal checking, factory acceptability, and site acceptance. The categorisation software is used to support the validation approach based on the computerised system's difficulty and individuality.

Categories of GAMP software may be open for interpretation. Often there can be some confusion as to which category a software application falls under. This may result in excessive or too little validation effort being performed.

Risk Assessment is used to identify, assess, monitor, and review the risks involved. It is then used to determine whether validation is required and how much validation is needed based on the level of risk and the impact on the system.

Why would the Validation Engineers work under GAMP Guidelines?

Since GAMP is a guideline rather than an industry regulation, it is vital to ensure that your validation engineers are up-to-date with the latest updates and work to the highest possible industry standards. An engineer who takes a measured approach is also needed to avoid completing too much or too little validation on each project when undertaking the risk assessment. This is where the validation engineers' expertise and credibility count.

The validation engineer's data works department works with GAMP V guidelines. They have extensive experience in life sciences validating software systems and automation to FDA standards-you can be assured that the skilled engineers will verify your software and equipment to the highest industry standards.


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