Ensuring FDA & GMP Compliance with SAP Integration Across Lab, ERP, and MES Systems

Industry

SAP S/4HANA integration for pharmaceutical industry ensuring GMP compliance, quality systems, MES, and FDA regulatory standards.

Industry

Pharmaceuticals & Life Sciences

The Client

A regulated pharmaceutical manufacturer with multiple production sites across North America, specializing in sterile injectables and biologics.

The organization required SAP integration that adheres to stringent FDA and GMP compliance requirements.

The Challenges

The client faced difficulties ensuring traceability and regulatory compliance across their manufacturing and quality control systems.

Key pain points included:

  • Lack of batch-level traceability between MES, LIMS, and SAP S/4HANA.
  • Incomplete audit trails for data exchanged between regulated systems.
  • Non-compliance risks with FDA 21 CFR Part 11 and GMP guidelines.
  • Manual review processes delaying batch release and quality approvals.

The Solution

Satva Solutions designed and implemented a validated SAP integration framework ensuring compliant data exchange between ERP, MES, and laboratory systems.

Key elements of the solution:

  • Compliant integration architecture: Developed a validated SAP PI/PO interface with digital signatures and audit-ready logs for every data transaction.
  • Batch traceability enablement: Automated synchronization of production batch data from MES to SAP S/4HANA, ensuring real-time genealogy and status visibility.
  • GMP-compliant workflow automation: Integrated LIMS data (test results, QC status) with SAP quality management modules under strict validation controls.
  • Validation and documentation: Delivered a full validation package—IQ, OQ, PQ documentation, audit reports, and traceability matrices aligned with FDA 21 CFR Part 11.

Key Features

  • FDA 21 CFR Part 11 compliant integration framework
  • End-to-end batch traceability across ERP, MES, and LIMS
  • Automated audit logging and exception tracking
  • Validation-ready documentation for regulatory audits

Results & Business Impact

  • Ensured end-to-end GMP and FDA compliance across all integrated systems
  • Reduced batch release time through automated data synchronization
  • Improved data integrity and traceability for audit readiness
  • Minimized manual interventions and compliance risks

Conclusion

Satva Solutions delivered a secure, validated SAP integration ecosystem enabling full traceability, compliance, and operational visibility.

By connecting SAP with MES and LIMS under regulatory standards, the client achieved faster quality approvals and reliable audit performance strengthening their compliance posture across all manufacturing sites.

Technology Stack

  • SAP S/4HANA
  • MES (Manufacturing Execution System)
  • LIMS (Laboratory Information Management System)
  • SAP PI/PO
  • SAP CPI
  • Validation Frameworks (GxP, 21 CFR Part 11)

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