Tag: EU GMP Annex 11

Never Approve Data Transfers in GMP Systems Without Prior Validation

November 8, 2025November 14, 2025 digi

Never Approve Data Transfers in GMP Systems Without Prior Validation Don’t Approve Data Transfers in GMP Systems Without Validation Remember: Always validate electronic data transfers between GMP systems — unvalidated transfers can compromise data integrity and traceability. Why This Matters in GMP GMP environments increasingly rely on electronic systems — LIMS, ERP, CDS, MES —…

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Secure GMP Networks with Role-Based Firewalls for Data Protection

October 27, 2025November 14, 2025 digi

Secure GMP Networks with Role-Based Firewalls for Data Protection Do Secure GMP Networks with Role-Based Firewalls and Access Controls Remember: Implement firewalls and role-based access controls to protect GMP networks from unauthorized access, data breaches, and system tampering. Why This Matters in GMP GMP-compliant networks support critical functions like data acquisition, batch release, LIMS, MES,…

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Assign Unique Digital Access Logs to Each GMP Data Terminal

October 24, 2025November 14, 2025 digi

Assign Unique Digital Access Logs to Each GMP Data Terminal Do Assign Digital Access Logs to Every GMP Terminal to Ensure Traceability Remember: Each GMP data terminal must maintain its own unique access log — this enables traceable, secure, and compliant data entry and review. Why This Matters in GMP Digital access logs provide a…

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Document Electronic System Access Privileges for GMP Data Security

October 16, 2025November 14, 2025 digi

Document Electronic System Access Privileges for GMP Data Security Do Document Electronic System Access Privileges for GMP Systems Remember: Always define and document access rights for all GMP electronic systems — this ensures traceability, security, and compliance with data integrity expectations. Why This Matters in GMP Electronic systems used in GMP — such as Laboratory…

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Never Use USB Drives in GMP Data Terminals Without Validation

October 15, 2025November 14, 2025 digi

Never Use USB Drives in GMP Data Terminals Without Validation Don’t Use USB Drives in GMP Data Terminals Without Control and Validation Remember: Never plug unvalidated USB drives into GMP systems — they can compromise data integrity, introduce malware, and breach regulatory controls. Why This Matters in GMP GMP data systems — including laboratory instruments,…

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Implement Automatic Backups for All GMP Quality Data Servers

September 29, 2025November 14, 2025 digi

Implement Automatic Backups for All GMP Quality Data Servers Ensure Auto-Backups Are Enabled for All Quality Data Systems Remember: Always implement automatic backups on GMP data servers — manual or missing backups jeopardize data integrity and business continuity. Why This Matters in GMP Electronic systems used in GMP operations house critical records — including test…

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Never Override HMI Control Panels During GMP Manufacturing Runs

September 21, 2025November 14, 2025 digi

Never Override HMI Control Panels During GMP Manufacturing Runs Do Not Override HMI Panels During GMP Production Runs Remember: Never override HMI (Human-Machine Interface) settings during active manufacturing — unauthorized changes compromise validated parameters and GMP compliance. Why This Matters in GMP HMI panels serve as the interface for monitoring and controlling manufacturing systems such…

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Never Deactivate Quality Alarms Without Investigating Root Cause

July 25, 2025November 14, 2025 digi

Never Deactivate Quality Alarms Without Investigating Root Cause Do Not Deactivate Quality Alarms Without Investigating the Cause Remember: GMP requires that every alarm be documented and investigated. Deactivating or ignoring quality alarms without root cause analysis compromises product safety and data integrity. Why This Matters in GMP Alarms on GMP equipment—such as HVAC units, stability…

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Ensure Audit Trails Are Reviewed During GMP Quality Management Reviews

July 1, 2025November 14, 2025 digi

Ensure Audit Trails Are Reviewed During GMP Quality Management Reviews Include Audit Trail Reviews in GMP Quality Management Activities Remember: GMP requires routine review of audit trails as part of Quality Management System (QMS) reviews to maintain electronic data integrity and accountability. Why This Matters in GMP Audit trails capture all activities within GMP electronic…

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Never Share Login Credentials for GMP-Regulated Software Systems

June 25, 2025November 14, 2025 digi

Never Share Login Credentials for GMP-Regulated Software Systems Do Not Share User Credentials for GMP Electronic Systems Remember: GMP-compliant systems require individual login credentials—shared access destroys audit trail integrity and violates data accountability rules. Why This Matters in GMP Electronic systems used in pharmaceutical manufacturing—such as LIMS, HPLC software, MES, and SCADA—are required to maintain…

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