Validation of commercial computerised systems using a single life cycle document (integrated validation document)

A risk‐based approach to the validation of low risk commercially available computerised systems is described. To determine if validation is required, the business process automated by the system is assessed to see if it is regulated. If validation is required, then the Good Automated Manufacturing Practice (GAMP) software category is mapped against the impact of the records generated by the system to determine if full or reduced validation is required. If reduced validation is indicated, the use of a single integrated validation document is proposed and illustrated with two case study examples. The use of a Validation Master Plan (VMP) to facilitate this validation process is also presented and described.