Computer system validation requires, first, that you obtain or design a process that can consistently conform to requirements; and then that you run studies demonstrating that this is the case. Both tasks can be performed with the aid of the right statistical tools. Briefly put, the requirements are:
- Development of a validation plan
- Utilization of Standard Operating Procedures (SOPs)
- Documented Training on SOPs
- Development of detailed specifications
- Development of a test plan and/or test scripts
Both the FDA and ISO 13485:2003 require computer system validation. Many regulated companies, however, still use unvalidated computer systems.
