FDA 21 CFR 11 – Pharma GMP

Secure GMP Networks with Role-Based Firewalls for Data Protection

digi — Mon, 27 Oct 2025 04:05:46 +0000

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,...

Assign Unique Digital Access Logs to Each GMP Data Terminal

digi — Fri, 24 Oct 2025 06:23:57 +0000

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...

Document Electronic System Access Privileges for GMP Data Security

digi — Thu, 16 Oct 2025 22:30:51 +0000

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...

Never Use USB Drives in GMP Data Terminals Without Validation

digi — Wed, 15 Oct 2025 11:14:57 +0000

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,...