Tag: GMP compliance gaps

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

No Revision Log or Audit Trail Maintained: GMP Audit Finding Explained

No Revision Log or Audit Trail Maintained: GMP Audit Finding Explained GMP Risk of Missing Revision Logs and Audit Trails in Document Control Introduction to the Audit Finding 1. Documentation Without History In GMP environments, every controlled document must have a revision log. Its absence leads to non-traceable changes. 2. No Change Visibility Without a…

GMP Audit Findings, Revision Control