What Additional System Documentation Is Required?
A traceability matrix should be created to demonstrate that each requirement is tested in the validation protocol. In addition, documentation needs to be in place to describe specifically how the system is to be used and maintained. User documentation can take the form of a set of procedures or a manual. Procedures work well in that they can be tailored to specific business roles and serve to complement more-generic system user manuals. Procedures covering system maintenance and data backup and recovery round out the system documentation set. Conclusion Software has many characteristics that make it easier to validate than equipment and that allow verification and validation activities to provide significant business value. Verification and validation can reduce the total cost of ownership of a system through defect reduction and improved work efficiency. Verification and validation should be incorporated into a project plan and should commence as early as possible during the execution
