Tag: EU GMP Annex 11

Review Audit Trails of Electronic Records as Part of GMP Oversight

June 25, 2025November 14, 2025 digi

Review Audit Trails of Electronic Records as Part of GMP Oversight Routinely Review Audit Trails to Ensure Electronic Record Integrity Remember: Audit trails must be periodically reviewed by QA or authorized personnel to detect data changes and uphold GMP data integrity standards. Why This Matters in GMP Electronic records are widely used in pharmaceutical operations,…

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Validate Software Used in GMP Data Acquisition Systems

May 19, 2025 digi

Validate Software Used in GMP Data Acquisition Systems Always Validate Software Used for Data Acquisition in GMP Remember: Any software system used for capturing GMP data must be validated to ensure accuracy, reliability, and regulatory compliance. Why This Matters in GMP In modern pharmaceutical manufacturing, electronic systems are commonly used to acquire, store, and report…

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Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

May 10, 2025 digi

Maintain Access Logs for Electronic GMP Systems to Ensure Accountability Keep Detailed Access Logs for Electronic GMP Systems Remember: Every login, action, or change in GMP electronic systems must be logged and traceable to ensure accountability. Why This Matters in GMP Electronic systems are integral to data collection, analysis, and product release decisions in pharmaceutical…

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Avoid Operating Equipment Without Completing Logbook Entries

May 2, 2025 digi

Avoid Operating Equipment Without Completing Logbook Entries Never Use Equipment Without Properly Completing Its Logbook Remember: Equipment must not be operated unless logbook entries for prior and current usage are accurately recorded. Why This Matters in GMP In GMP-compliant environments, every piece of equipment has its own identity and operational history. Equipment logbooks serve as…

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