Manufacturing Execution Systems in the Life Sciences

SAP Digital Manufacturing in a regulated environment – How GxP-ready is SAP DM really?

In the first part, we outlined the role of modern MES/MOM systems in the manufacturing industry. This second part focuses specifically on SAP Digital Manufacturing and the question of how GxP-compliant SAP DM actually is today—based on real-world experience from MedTech and Pharma.

The digitalization of manufacturing is at the top of the agenda for regulated industries. Both medical technology and pharmaceutical companies are seeking modern, integrated production systems that enable efficiency gains while simultaneously meeting the strictest regulatory requirements. With SAP Digital Manufacturing (SAP DM), SAP positions itself as a cloud-based, globally scalable solution. But how suitable is SAP DM actually for GxP-critical processes—and what differences exist between medtech and pharma?

While the pharma industry is closely bound by regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Guidelines, the medtech industry is more strongly oriented toward ISO standards such as ISO 13485, ISO 14971, IEC 62304, and the MDR. Both industries demand high standards in traceability, documentation, and data integrity, albeit with varying degrees of regulatory depth. This is precisely what determines how well SAP DM can be deployed in each respective environment.

Why SAP DM is of interest to regulated industries

Regulated manufacturing companies expect more from modern MES/MOM systems than just digitized work steps. They require guided, standardized processes, end-to-end electronic documentation, and traceable signatures—embedded in an integrated system landscape without media breaks. While many established MES solutions have historically been operated on-premises and heavily customized, SAP DM takes a clear cloud-based and standardization approach. This reduces operating costs in the long term, increases the frequency of updates, and streamlines integration with SAP S/4HANA, QM, and logistics processes.

MedTech companies in particular benefit from this, as their ISO-based quality management systems are already process-oriented and risk-based. Pharmaceutical manufacturers, on the other hand, require additional security: audit trails, role models, electronic signatures, and data flows must be fully GMP-compliant—here, SAP DM has its strengths and weaknesses.

Initial practical experience from the MedTech industry

SAP DM has been in productive use at MedTech companies such as Carl Zeiss Meditec since 2022, for example in assembly, final inspection, or other production processes requiring documentation. The implementation typically aims for complete digitalization of manufacturing, deep integration with SAP S/4HANA, and valid, GAMP 5-compliant processes.

The guided operation via Fiori interfaces stands out as particularly positive, reliably guiding employees through standardized process flows and reducing operational errors. Measurement values, material consumption, and inspection decisions are consistently documented, and the existing signature functionality meets key ISO requirements. At the same time, it is clear that for pharmaceutical scenarios with stricter regulatory requirements, issues such as audit trails, data integrity, and change tracking are key hurdles.

Audit Trail & Data Integrity – The Critical Litmus Test for Pharma

Pharmaceutical companies require tamper-proof audit trails, clear change tracking without silent corrections, regular audit trail reviews, and unambiguous, context-sensitive electronic signatures. While technical logs were available in earlier SAP DM versions, auditors-friendly audit trails were often missing. As a result, companies frequently addressed this gap with organizational controls, role restrictions, or additional logs on the SAP BTP.

With Release 2508, the audit functions were significantly expanded: More objects are auditable, changes are reported more clearly, and actions requiring signatures are presented in a more traceable manner. Nevertheless, SAP DM remains only partially suitable for fully regulated pharmaceutical manufacturing processes—depending on the exact application scenario.

Blueprint for the First Pharmaceutical Project

A pragmatic approach for the pharmaceutical sector can be derived from successful medtech implementations. It makes sense to define a deliberately limited and easily controllable scope, such as in packaging, line routing, or in-process controls. Areas like bulk production or sterile manufacturing, on the other hand, are not suitable as a starting point.

Based on this, a detailed GxP analysis of all relevant SAP DM functions follows, particularly those objects that are subject to mandatory audit trails or require regulatory signatures. Validation is typically risk-based in accordance with GAMP 5 or the FDA CSA (Computer Software Assurance) approach, which builds upon the classic CSV methodology as a modern, risk-based validation approach of the U.S. FDA. It places greater emphasis on product-related risks and effective testing strategies rather than excessive documentation.

A clear architectural decision is also essential: In many pharmaceutical scenarios, ERP, LIMS, or a dedicated eBR remains the primary system, while SAP DM acts as the operational front end. This blueprint is not a theoretical construct but is based on real-world experience with SAP DM in regulated environments. As early as 2025, the first successful SAP DM go-live in the pharmaceutical industry took place, utilizing targeted workarounds to fully address regulatory requirements. These project experiences demonstrate that SAP DM is fundamentally suitable—though this depends on the use case and requires additional measures to close GxP gaps.

SAP DM is currently undergoing dynamic development. SAP is investing heavily in the system’s GxP maturity and, together with development partners, is expanding new features to gradually adapt the solution to the requirements of strictly regulated pharmaceutical manufacturing processes.

Electronic Signatures – Part 11 and Annex 11 Compliance

SAP DM supports single and dual signatures, re-authentication, and the storage of relevant signature contexts. This provides the technical foundation for Part 11 compliance. However, whether a process can be operated in a GMP-compliant manner depends heavily on the specific design of the workflows, the system architecture, and the audit trail capability of the respective objects.

SAP DM Release 2508 – An Important Milestone

With Release 2508, SAP has made significant progress: The audit trail has been expanded, made more structured, and easier to read; changes are more closely linked to signature events. For MedTech, this already means broad usability today. For Pharma, it marks an important but not final step.

SAP BTP Activity Log – A Supplement, but Not a GMP Audit Trail

The SAP BTP Activity Log offers valuable technical diagnostics and system monitoring. However, it is not suitable for GMP-compliant audit trail requirements, as it logs technical rather than business events, does not provide “reason-for-change” logic, and cannot be used for audit trail reviews.

Conclusion – SAP DM Is Ready for MedTech, on the Way for Pharma

SAP Digital Manufacturing is already GxP-compliant for medical technology today, as the requirements of ISO standards are well supported. For the pharmaceutical industry, SAP DM can be used if its deployment is deliberately focused on suitable process areas and supplemented by additional validation measures. With Release 2508, SAP has closed key gaps, particularly regarding the audit trail. Upcoming releases will determine how quickly SAP DM can be widely deployed in a fully GMP-regulated environment.

Companies that start today benefit from a modern, future-proof platform approach—and lay the foundation for long-term regulatory compliance.

Further articles in this series:

• Manufacturing Execution Systems in the Manufacturing Industry