ERP systems validation
Validation of ERP systems (SAP, JDEdwards, Navision, Alfa WS, etc.) implies a considerable effort in terms of resources, because it is vital to focus on the elements that are essential to the validation.
These elements are:
- Those areas or functions that are affected by GxP fulfillment.
- Those processes that, while affected by the GxP fulfillment, are the most critical not only for the business but also to demonstrate regulatory compliance.
In this sense the validation must withstand a rigorous Risk Analysis that would highlight possible weaknesses in the process that, as a consequence, would compromise the fulfillment of the regulations.
Given that the majority of cases involves the use of ERP coupled with activities that are documented using hard-copy (hybrid systems cf 21 CFR Part 11), the Risk Analysis should not only cover the system functionality, but also cover the uses of the ERP system within the organization having GxP relevance.
Starting with a good definition of the Risk Analysis, the Operational Qualification (OQ) is centered on the verification of the adequate control of the identified risks.
The validation methodology for the ERP should always be adapted to the type of organization, its processes, company size, etc.
For corporate ERPs the general strategy is defined in a Master Validation Plan that covers the validation of the common elements of the organization. Subsequently for every implementation in the company/division/department of the corporation, a Roll-out plan establishes the strategy and specific activities of the validation.