Ensuring Compliance, Data Integrity, and Operational Efficiency

Enterprise Resource Planning (ERP) systems like SAP play a critical role in managing business processes, supply chains, finance, and compliance in regulated industries such as pharmaceuticals, biotechnology, medical devices, and clinical research. Ensuring these systems function correctly while meeting FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulatory requirements is crucial.

At SmartSPOC, we provide comprehensive SAP/ERP Validation services to ensure compliance, data integrity, and seamless business operations.

Objective of SAP / ERP Validation

SAP/ERP Validation aims to verify that all modules, configurations, integrations, and customizations within the system operate as intended while maintaining GxP compliance, data security, and regulatory adherence. The validation process ensures:

• System reliability and accuracy in processing critical business data
• Compliance with industry regulations and best practices
• Protection of electronic records and audit trails
• Reduction of risks associated with system failures and non-compliance

Key Phases of SAP / ERP Validation

Planning & Risk Assessment – Identifying business and regulatory requirements, defining validation strategy

System Specification & Design – Documenting functional and technical specifications, ensuring compliance with 21 CFR Part 11 & GAMP 5

Configuration & Development – Customizing the system, integrating modules, implementing security controls

Testing & Qualification – Performing IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to validate system functionality

Validation Documentation – Preparing validation plans, risk assessments, traceability matrices, and user manuals

User Acceptance Testing (UAT) – Ensuring the system meets business and regulatory requirements before deployment

System Go-Live & Monitoring – Continuous monitoring, audit trails, and compliance checks

Change Control & Periodic Review – Managing updates, modifications, and revalidation

Decommissioning & Data Migration – Secure system retirement while ensuring data integrity

Why Choose SmartSPOC for SAP / ERP Validation?

Compliance with Global Standards - FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SOX, GDPR

Extensive Industry Experience - Pharmaceuticals, Biotech, Medical Devices, Clinical Research

Comprehensive Validation Approach - Covering all SAP modules (SAP S/4HANA, SAP ECC, QM, MM, SD, PP, FI, etc.)

Risk-Based Validation - Focused on critical business and regulatory risks

End-to-End Support - From planning and validation to continuous compliance monitoring