Software Validation Requirements Industry Practice. 8 Best practices to write them The collection the analysis and the documentation of requirements are essential all along the life cycle of a software project. To check issues related to requirements we perform requirements validation.
Validating the software helps reduce risk and legal liability as well as providing evidence that the computer system is fit for purpose. The GAMP Guide may be referred to as appropriate for more detailed guidance. However there is not much understanding of the actual requirements and the best practices for meeting the requirements in the industry.
Requirements validation makes sure that the requirements written in software requirements specification SRS must be complete and consistent and are according to the customers needs.
Requests that a controlled process is instigated or an existing controlled process requires a serious modification miner modification would be controlled under change control a User Requirement Specification URS document is raised. Use a risk-based approach when making a plan for software validation. The FDA defines software validation as Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses and that the particular requirements implemented through software can be consistently fulfilled. Other design controls such as planning input verification and reviews are.