Tag: data integrity audit

SOP Gaps in Data Correction Documentation: Risk to GMP Integrity

SOP Gaps in Data Correction Documentation: Risk to GMP Integrity GMP Risk: SOP Lacks Guidelines for Documenting Data Corrections Introduction to the Audit Finding 1. SOP Omits Correction Protocols Key GMP records are corrected without following any defined method or procedure. 2. No Consistency in Corrections Corrections vary between operators—some overwrite, others use white-out or…

Data Integrity Gaps, GMP Audit Findings

No Policy for Electronic Signatures: A Data Integrity Red Flag in GMP Systems

No Policy for Electronic Signatures: A Data Integrity Red Flag in GMP Systems Missing Electronic Signature Policy: A Risk to Data Integrity and GMP Compliance Introduction to the Audit Finding 1. Undefined e-Signature Protocols Organizations lack written procedures governing electronic signatures used in GMP operations. 2. Violation of 21 CFR Part 11 Absence of a…

Data Integrity Gaps, GMP Audit Findings