Transcription of Audit Trail Predicate Rules - Compliancewire
1 CitedGxPRegulatory requirement All changes to the be documented, maintained with the protocol. Master production records shall be prepared, dated, and signed by one person and independently checked, dated and signed by a second person. All data shall be recorded and signed or initialed by person entering. Any change in entries shall not obscure original entry and indicate reason for change and person and date of change. Any change to automated data entries shall be made so as not to obscure the original data, indicate reason for change and dated and identify responsible person.
2 Documentation of each significant dates,..and identification of persons performing and directly FDA's final guidance on Computerized Systems Used in Clinical Investigations (May 2007) states that the recommendations in this guidance would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR (b) and (b), such as case histories. Design output shall be documented, reviewed, and the date and signature of the individual approving the output. Audit Trail Predicate Rules
