Enterprise Resource Planning (ERP) system validation is essential in regulated industries, particularly pharmaceuticals, biotechnology, and medical devices, where ERP systems manage key operations like inventory, production, quality control, and distribution.
Requirements Gathering
User Requirements Specification (URS): Document what the users need from the ERP system, including both functional (what the system should do) and non-functional (performance, security) requirements.
Functional Requirements Specification (FRS): Define detailed functions and operations of each ERP module that is critical for regulatory compliance, such as audit trails, data access controls, and electronic signatures.
Regulatory and Compliance Requirements: Include specific regulatory requirements, such as FDA 21 CFR Part 11 for electronic records and signatures or EU Annex 11 for data integrity.
Operational Qualification (OQ)
Functional Testing: Test each ERP function to verify it performs as intended under normal and stress conditions. This includes key functions like inventory management, batch records, production scheduling, and quality control.
Security and Access Control Testing: Test user access controls, role-based permissions, and ensure data security mechanisms meet regulatory requirements.
Audit Trail and Data Integrity Testing: Validate that the ERP system’s audit trail records user activities, document changes, and protects data integrity.
Workflow and Process Testing: Verify that business workflows (such as production orders, quality checks, and release for distribution) function correctly and maintain required compliance standards.
Performance Qualification (PQ)
End-to-End Process Validation: Validate the ERP system in a real or simulated production environment, testing it with actual users and realistic workloads to ensure it meets performance standards.
Data Flow Validation: Confirm that data flows accurately between ERP modules and any integrated systems, such as MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), or WMS (Warehouse Management System).
System Integration Testing: Validate integration with other systems, ensuring data is transferred accurately and securely. For example, verify that inventory data in the ERP matches data in other related systems.
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Resource Person: Mohamed Mahmoud