With the mainstream support for SAP ECC6 ending in 2027 and extended maintenance available only until 2030 at an additional cost, Pharmaceutical and Medical Device manufacturers are facing a critical decision: how to upgrade their ERP systems in a way that meets both business goals and regulatory obligations. The move to SAP S/4HANA presents a significant opportunity, but in regulated industries, it must be approached with compliance and validation front of mind.
There are two common approaches to upgrading from ECC6 to S/4HANA.
1. Technical Lift-and-Shift
This method involves migrating the existing ECC6 system to the S/4HANA platform without changing business processes or data flows. It is often faster, less disruptive, and requires fewer internal resources.
- Advantages
- Shorter project timeline
- Lower immediate risk and complexity
- Familiar system for users
- Considerations
- Limited opportunity to modernise or streamline operations
- Legacy inefficiencies are retained
- Still requires validation, since the underlying platform and data structure change
2. Digital Transformation
This approach takes full advantage of S/4HANA’s capabilities by redesigning business processes and data structures as part of the upgrade. It’s a strategic opportunity to drive innovation, efficiency, and agility across the organisation.
- Advantages
- Enhanced business performance
- Improved compliance monitoring, reporting, and traceability
- Future-proofing your digital infrastructure
- Considerations
- Longer project timelines
- Greater resource requirements
- More complex validation due to the number of changes
The right approach depends on your organisation’s business objectives, compliance priorities, timeline, and available resources. Regardless of which path is chosen, validation remains a regulatory requirement.
Why Validation Matters for Regulated Industries
SAP S/4HANA is typically implemented as a GxP-relevant system — meaning it directly impacts product quality, safety, or data integrity. Therefore, regulators such as the FDA, TGA, and the European Medicines Agency require formal computer system validation (CSV) for its implementation or upgrade.
Compliance must be demonstrated against:
- 21 CFR Part 11 – Electronic records and signatures (FDA)
- Annex 11 of PIC/S Guide to GMP PE009-17 – Computerised systems (EU/TGA)
- FDA Data Integrity Guidance – ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate
Whether your project is a lift-and-shift or a full digital transformation, validation is essential to ensure data integrity, traceability, and control over your business-critical systems.
Leveraging Your SAP Integration Partner’s Deliverables
SAP integration partners will produce a significant amount of technical and configuration documentation during the project. While valuable, this documentation:
- Is often technically focused and not tailored to regulatory requirements
- Typically lacks a risk-based validation approach
- Needs to be interpreted and supplemented to meet CSV standards
You should leverage these outputs to reduce duplication, but ensure they are reviewed and documented appropriately to satisfy compliance expectations.
How SeerPharma Can Support Your Upgrade
SeerPharma specialises in computerised system validation for life sciences and has extensive experience in supporting SAP implementations and upgrades. Our team can:
- Define your validation strategy: Align your validation approach with business goals and compliance requirements, whether you choose lift-and-shift or digital transformation.
- Prepare and review validation documentation: Including URS, risk assessments, traceability matrices, test protocols, and summary reports.
- Oversee regulatory compliance: Ensure the entire upgrade process is aligned with 21 CFR Part 11, Annex 11 (PIC/S PE009-17), and FDA Data Integrity expectations.
- Assess technical documentation: Evaluate deliverables from your SAP integration partner to ensure they are suitable for validation and audit readiness.
- Provide independent assurance: We act as a compliance partner, ensuring your implementation is both technically successful and audit-ready.
Conclusion
Upgrading to SAP S/4HANA is not just a technical milestone — it’s a regulated change with lasting implications for your quality systems, data integrity and audit preparedness.
Whether you opt for a faster lift-and-shift or a transformational reengineering of your business processes, validation is non-negotiable. Partnering with experienced compliance professionals like SeerPharma ensures your project meets regulatory expectations while supporting your broader business objectives.
Contact us to explore how we can help you navigate the compliance requirements, streamline validation and achieve a successful, audit-ready system implementation.
