Evolution of a companywide validation program.

Abstract

A successful computer validation program requires a solid foundation of policies, guidelines, and procedures. An unstructured approach to validation may yield adequate results for a specific computerized system, but it will not sustain ongoing, consistent computer validation activities over time. The evolution of a strong computer validation program starts with an awareness of the need for such a program and builds on that established base. One approach is a step-by-step method in which each new step builds on the results of one or more of the previous steps. However, the order of events is not as important as the ultimate completion of all the building blocks. A strong computer validation program requires a companywide policy and an administrator who provides oversight and chairs the computer validation committee. The committee should be established to provide departmental leadership and to develop company guidelines for computer validation. Committee members will also create system inventories and classify and prioritize those systems in terms of the need for validation. Departmental standard operating procedures must be developed to provide standardized methods for routine validation activities. Finally the quality assurance unit should have procedures in place that provide for its involvement in the computer validation process.