- Validation Master Plan for ERP
- URS for ERP
- Annexure I
- Annexure II
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification of ERP
- Risk Assessment for ERP
✅ What is ERP Validation?
ERP (Enterprise Resource Planning) Validation means providing documented evidence that the ERP system:
- Works as intended consistently and reliably.
- Meets regulatory requirements (e.g., GMP, GAMP 5, 21 CFR Part 11).
- Ensures data integrity, traceability, and compliance across functions (inventory, production, quality, finance).
🎯 Why is ERP Validation Important?
- ERP systems manage GxP-relevant data, such as:
- Batch records
- Material traceability
- Release status
- Electronic signatures
- Regulatory agencies expect validation of computerized systems to avoid data loss, errors, and compliance risks.
🛠️ Key Components of ERP Validation
| Component | Details |
|---|---|
| User Requirements (URS) | Define what the system must do. |
| Risk Assessment | Identify GxP impacts, data integrity risks, and mitigation plans. |
| Functional Specifications | Describe how the system will fulfill requirements. |
| Validation Plan | Outline 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 Verification | Ensure data transferred correctly from legacy systems. |
| Security & Access Control Testing | Confirm permissions, roles, and electronic signatures. |
| Training & SOPs | Ensure users are qualified to operate the system. |
| Validation Report & Approval | Summarize results and formally release the system. |
🔹 GAMP 5 Approach
ERP systems are typically GAMP Category 4 or 5 (configured or bespoke).
Validation follows:
- Risk-based approach (focus testing on GxP-critical areas).
- Supplier assessment and audit.
- Supplier documentation leverage (FAT/SAT).
🧪 Examples of GxP-Relevant ERP Functions
- Material master data control.
- Batch production records.
- Electronic batch release workflows.
- Controlled inventory and expiry management.
- Audit trail and data retention.
📘 Reference Guidelines
- EU GMP Annex 11 – Computerized Systems
- FDA 21 CFR Part 11 – Electronic Records and Signatures
- ISPE GAMP 5 – Good Automated Manufacturing Practice