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Validation

 

IPERION offers a start-to-finish solution for validating an information system according GAMP5 . We use a risk based approach that together with example policies and templates will guide through the process from planning to "go live" . We leverage as much as possible on the validation material of the vendors but remain to have an open mind in what approach fits best with the customer. No problem to adopt customer’s own validation approach as long as we are able to add our value based on the extensive system know-how.


This is also how we want the customer to experience our validation approach:

•    Aimed at verifying that the systems is fit for purpose;
•    Knowledge how the system works is made explicit and documented;
•    Policies and procedures are set to maintain the system in a validated status.