VAL003b Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal^SM Life Cycle)

The procedure describes the activities and deliverables for the 9-phase RiskVal Life Cycle^(SM). The objective of the life cycle is to ensure that the system reliably meets the organization’s needs. The Life Cycle is an integration of system implementation, the management of risks associated with computer system failure, and validation. The phases include: Conceptualize, Define Requirements, Select Vendors and Systems, Design Solutions to Issues (meeting requirements, achieving compliance, and risk mitigation), Prepare to Use, Qualify the System (IQ and OQ testing), Use in a Production Environment (PQ and change control), and Retire the System.

This procedure includes the same deliverables as the another procedure also available on this website, Validation of Computer Systems Used in Production and Quality Systems (RiskVal), only this procedure uses the RiskVal Life Cycle phases as a framework. This procedure corresponds to the procedure described in Deliverable 1.2 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.