TEMP002 Validation Plan Template for Single System Validations (RiskVal^SM)

In addition to providing guidance on how to explain the impact of risk and the validation approach, this template provides guidance and examples on aspects of a validation plan that are often overlooked, such as: how the system implementation strategy affects the validation strategy, the system maintenance and support strategy, training requirements for those involved with the validation, the specification of prerequisites and acceptance criteria for the validation protocols (IQ, OQ, PQ), revalidation criteria, and system acceptance criteria.

This template is part of the RiskVal Life Cycle^(SM) series of computer system validation documentation. It corresponds to the plan described in “Deliverable 4.2 Validation Plan" in Appendix A of Computer System Risk Management and Validation Life Cycle written by the author of this template, Tim Stein, and published by Paton Professional, 2006.