Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance.
Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity.
The CSV Engineer is responsible for ensuring that all manufacturing process, QC and Enterprise systems perform and operate as per their design. The CSV Engineer ensures that all systems, conform to relevant regulatory requirements as well as company specifications and standards.
CSV Specialists plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements.