ABSTRACT
After placing the emphasis on e-records integrity by the worldwide regulatory agencies or competent authorities, the regulated industry is providing the same attention to the system life cycle and the e-records life cycle. To avoid additional work and as part of the computer system workflows, it is relevant to incorporate integrity-related controls to the e-records and build in the correct management of e-records during processing. Computer systems validation is the formal assessment and reporting of quality and performance measures for all the life cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, re-qualification, maintenance, and retirement. Business requirements are gathered as part of the feasibility at the beginning of the computer system project, including the e-records integrity-related requirements. These e-records integrity-related requirements are traced to the regulated company e-records governance.
