ABSTRACT
The computer systems validation process incorporates "planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering that together help to support a final conclusion that software is validated." A quality management system (QMS) defines all activities of the management function which influence the quality of a product. It is the total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. An element in the e-records governance is the computer validation process. This process provides the initial assurance of the successful implementation of the e-records integrity controls. Changes to the computer system, including migration of data, should be made according to a change procedure and should be formally authorized, documented and tested.
