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GMP Pocket Guide Volume...

Question of the Week

What basic functions and aspects must an electronic batch recording (EBR) system have to ensure compliance with GMP requirements?

GMP-relevant functions and properties of an EBR System
  • Suitability of the system for validation
  • Audit trail (electronic)
  • Electronic signature
  • Electronic (long-term) archiving
  • Data consistency
  • Data security
  • Failsafe state of the system
  • User administration/rights management
  • Reporting functions (reports, printouts)
[GMP MANUAL, Chapter 15.F.4]

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