VAL006 Computer System Project Proposal (RiskVal^SM)

A computer System Project Proposal provides information about the system that management needs to authorize the initiation of a formal IT project. Information is collected on the value of the system, the risks it poses, the applicability of 21 CFR Part 11 regulations, whether the system must be validated, and the magnitude of the implementation. The form is to be completed for every new system that an individual wants to bring into the organization. The evaluation of the form by the system owner, IT, and QA enables the organization to determine if it wants the new system, to fit it into its priorities for new systems, and to plan ahead for its implementation.

This procedure is part of the RiskVal Life Cycle^(SM) series of computer system validation documentation. It corresponds to the procedure described in "Deliverable 1.5 Computer System Project Proposal” in Appendix A of Computer System Risk Management and Validation Life Cycle written by the author of this procedure, Tim Stein, and published by Paton Professional, 2006.