EU Annex 11 – Pharma GMP

Never Share Passwords for Access-Controlled GMP Data Systems

digi — Wed, 03 Sep 2025 04:09:30 +0000

Never Share Passwords for Access-Controlled GMP Data Systems Do Not Share Passwords for Access-Controlled GMP Systems Remember: Never share login credentials in GMP systems — individual accountability is essential to uphold data integrity and regulatory compliance. Why This Matters in GMP In GMP environments, access to electronic systems — such as LIMS, SCADA, or eQMS...

Never Rely on Electronic Signatures Without System Validation

digi — Wed, 20 Aug 2025 19:59:43 +0000

Never Rely on Electronic Signatures Without System Validation Don’t Use Electronic Signatures Unless Systems Are Validated Remember: Electronic signatures must only be used on GMP records if the system has been validated for compliance with applicable regulations like 21 CFR Part 11. Why This Matters in GMP Electronic signatures have become standard in modern GMP...

Implement Controlled Access to Data Entry Terminals in GMP Areas

digi — Sun, 04 May 2025 00:33:09 +0000

Implement Controlled Access to Data Entry Terminals in GMP Areas Ensure Controlled Access to GMP Data Entry Terminals Remember: Only authorized personnel should access GMP data terminals using secure login credentials. Why This Matters in GMP Unrestricted or shared access to data entry terminals increases the risk of data manipulation, unauthorized changes, and loss of...