data falsification – Pharma GMP

Data Integrity Breaches That Led to Site Bans

digi — Tue, 02 Sep 2025 22:43:25 +0000

Data Integrity Breaches That Led to Site Bans How Data Integrity Breaches Resulted in Pharma Site Bans Introduction: Why This Topic Matters for GMP Compliance Data integrity is the cornerstone of Good Manufacturing Practice (GMP). Regulators such as the FDA, EMA, and WHO expect that all records—whether paper-based or electronic—accurately reflect manufacturing and testing activities....

Never Sign Blank Fields in Controlled GMP Documents

digi — Fri, 30 May 2025 00:53:13 +0000

Never Sign Blank Fields in Controlled GMP Documents Signing Blank Fields in GMP Documents Is a Major Violation Remember: GMP documents must never be signed if data fields are blank—doing so risks falsification and breaches data integrity standards. Why This Matters in GMP Controlled documents like batch records, logbooks, and quality forms require complete, accurate,...