Transcription of Audit Trail Predicate Rules - Compliancewire
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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.
58.120 58.130 211.186 GLP GLP GMP CFR cited GxP Regulatory requirement “All changes to the protocol…shall be documented, signed…and dated…and maintained with ...
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