Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
Information technology SOP

โœ… What is ERP Validation?

ERP (Enterprise Resource Planning) Validation means providing documented evidence that the ERP system:


๐ŸŽฏ Why is ERP Validation Important?


๐Ÿ› ๏ธ Key Components of ERP Validation

ComponentDetails
User Requirements (URS)Define what the system must do.
Risk AssessmentIdentify GxP impacts, data integrity risks, and mitigation plans.
Functional SpecificationsDescribe how the system will fulfill requirements.
Validation PlanOutline strategy, deliverables, responsibilities, and timelines.
Installation Qualification (IQ)Verify correct installation/configuration.
Operational Qualification (OQ)Test core functions and workflows.
Performance Qualification (PQ)Verify system in real-life scenarios.
Data Migration VerificationEnsure data transferred correctly from legacy systems.
Security & Access Control TestingConfirm permissions, roles, and electronic signatures.
Training & SOPsEnsure users are qualified to operate the system.
Validation Report & ApprovalSummarize results and formally release the system.

๐Ÿ”น GAMP 5 Approach

ERP systems are typically GAMP Category 4 or 5 (configured or bespoke).
Validation follows:


๐Ÿงช Examples of GxP-Relevant ERP Functions


๐Ÿ“˜ Reference Guidelines

  1. Validation Master Plan for ERP
  2. URS for ERP
  3. Annexure I
  4. Annexure II
  5. Design Qualification
  6. Installation Qualification
  7. Operational Qualification
  8. Performance Qualification of ERP
  9. Risk Assessment for ERP

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