We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Computerized Audit Trails for Clinical Trials a Must
Computerized Audit Trails for Clinical Trials a Must
August 8, 2007
Although the FDA altered its recommendations in a recent guidance for audit trails of computer systems used in documenting clinical trial results, sponsors should still carefully consider how to comply with audit trail requirements under the agency’s 21 CFR Part 11 regulation, according to former FDA official Stan Woollen.