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Home » Firms Should Still Carefully Consider Audit Trails for Clinical Trial Systems
Firms Should Still Carefully Consider Audit Trails for Clinical Trial Systems
August 2, 2007
Although the FDA altered its recommendations in a recent guidance for audit trails of computer systems used in documenting clinical trial results, manufacturers should still carefully consider how to comply with audit trail requirements under the agency’s Part 11 regulation, according to former FDA official Stan Woollen.