TEMP007 Validation Final Report Template (RiskVal^SM)

The instructions and examples in this template provide a guide for how the final report for a validation is written. The validation approach is explained, including the implications of the system’s risk level for that validation. The final report also includes an analysis of how well the high- and moderate-risk functions worked, the effectiveness of risk mitigations, and an assessment of the residual risk. A summary of a risk/benefit analysis is included if the system remains at the high-risk level. The instructions and examples for the “Analysis of the Validation Results” section include a table with the listing of deliverables that could form the validation record. This table is easily edited to match your validation.

This template is part of the RiskVal Life Cycle^(SM) series of computer system validation documentation. It corresponds to the report described in "Deliverable 8.3 Validation Final Report" 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.