Moving beyond the document in computer systems validation
Over the years, we have seen a steady increase in companies moving away from paper-based validation to electronic-based approaches after the FDA introduced 21 CFR Part 11, which addresses the use and control of electronic signatures and electronic records. When utilized correctly, 21 CFR Part 11 opens the door to numerous potential process and solution improvements in computer systems validation, yet many teams have failed to take full advantage of these improvements.