Qualification Services for ERP Platforms in Life Sciences

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We develop all foundational lifecycle documentation, including:

• Validation Master Plan (VMP) or ERP Validation Framework
• GxP impact and process mapping
• Risk assessments based on ISPE GAMP 5
• Regulatory compliance alignment (FDA, EMA, MHRA, PMDA, WHO)

We qualify each ERP module according to its GxP relevance:

• Quality Management (QMS)
• Manufacturing Execution (MES integration)
• Warehouse Management / Inventory
• Procurement & Supplier Management
• Finance & Traceability
• Serialization & Supply Chain

We qualify interfaces between ERP and:

• LIMS
• MES
• QMS
• Serialization systems
• Equipment systems and IoT devices
• External partners (CMOs, 3PLs, suppliers)

This ensures reliable data flow and end‑to‑end process control.

Our team develops and executes test scenarios that reflect real business processes:

• Positive and negative testing
• Role-based access validation
• Security and segregation‑of‑duties (SoD) testing
• Part 11 and Annex 11 electronic records & signatures checks
• Audit trail review and data integrity verification

ERP systems evolve — and regulators expect you to maintain control. We provide:

• GxP-driven change control
• Periodic review & health checks
• Patch and update impact assessments
• Annual system validation reports
• Continuous documentation updates