SAP Public Cloud: From Validation Challenges to Automation

Public cloud solutions such as SAP Digital Manufacturing increase the pressure to validate systems in regulated companies due to frequent releases, short testing windows, and stringent documentation requirements. The DHC Smart Validation Accelerator demonstrates how these challenges can be managed through automation, traceability, and digital validation processes.

Thomas Pauly, Practice Manager - IT Compliance, DHC GmbH

Anyone in the life sciences industry who uses public cloud solutions such as SAP Digital Manufacturing is familiar with the dilemma: The cloud promises flexibility and scalability—but at the same time, it delivers a pace of change that pushes traditional validation approaches to their limits. Four releases a year, changes at the infrastructure, platform, and application levels—and in between, a validation process that was originally designed for more static on-premises systems.

The question isn’t: Do I have to validate? The answer is clear. The key question is: How do I validate efficiently enough to keep up with the speed of the cloud—while still remaining GxP-compliant?
This is exactly where the DHC Smart Validation Accelerator (SVA) comes in.

The problem: Frequent changes clash with documentation-intensive processes

Public cloud solutions are subject to continuous change—and this occurs simultaneously across multiple levels. At the application level, SAP Digital Manufacturing delivers new releases on a quarterly basis. Beneath this lies the platform layer—in the case of SAP solutions, for example, the SAP Business Technology Platform (BTP), which serves as the technical runtime and integration environment and follows its own release cycles. The infrastructure, in turn, is operated through hyperscalers such as Microsoft Azure or Google Cloud. All three layers are continuously evolving—independently of one another and without customers having any direct influence over them. SAP Digital Manufacturing (SAP DM) provides a concrete example of this architecture. It is a public cloud MES (Manufacturing Execution System) running on SAP BTP and serving as the link between ERP systems and the shop-floor level, where it controls GxP-critical processes. SAP DM is representative of a growing number of public cloud solutions used by regulated companies today. For regulated companies, this means that every release triggers a series of necessary validation activities:

Impact assessment: Which processes are affected by the changes?
Regression testing: Which test cases need to be executed again?
Documentation updates: Which validation documents need to be revised?

The SAP DM example makes this particularly clear: customers effectively have only two weeks to complete this entire process—a timeframe that is realistically manageable with a traditional document-based approach only at a very high cost and effort. In addition, the pace of change is entirely determined by the cloud service provider. Regulated companies have no influence over it.

The Answer: Digitization and Automation of Validation

DHC has developed a clear response to this challenge: the DHC Smart Validation Accelerator. Instead of relying on Word documents and Excel spreadsheets, the SVA provides a database-supported validation platform in which requirements, risks, specifications, and test cases are captured digitally, linked automatically, and maintained consistently throughout the entire system lifecycle. A key feature of the SVA is that validation artifacts are not created manually: they are automatically generated from the SAP Cloud ALM content for the respective application. This means that specifications, risk analyses, and test cases are not produced through labor-intensive document work. Instead, they are generated automatically based on the content stored in the system—consistently, comprehensively, and ready for audit immediately. The central element for ongoing operations is the Change Impact Analyzer. Based on the cloud provider’s release notes, it automatically identifies which parts of the validation documentation and which testing scope are affected by a new release. This eliminates the time-consuming manual impact assessment that previously accounted for a significant share of the validation effort after each update. The Change Impact Analyzer is a core component that makes validation scalable in the cloud era. At the heart of the solution is the Traceability Matrix. It transparently shows how processes, requirements, technical implementations, risks, and test cases are interconnected. This end-to-end traceability enables the SVA to automatically generate an impact assessment for each new release and determine the required testing scope.

The Digital Validation Platform Initiative:
SAP and DHC are building an End-2-End Toolchain

The DHC Smart Validation Accelerator is not intended to be a standalone tool, but rather an integral part of a broader initiative: the Digital Validation Platform (DVP). SAP launched this initiative in collaboration with select partners—including DHC—to provide life sciences customers with an end-to-end, digital toolchain for validation.

The toolchain connects established SAP solutions with specialized partners:

LeanIX: Inventory and Identification of Systems
Signavio: Process Modeling and Business Process Master List
SAP Cloud ALM: Requirements, Change, and Test Management
DHC Smart Validation Accelerator:
Validierungsdokumentation, Traceability, Risikomatrix
Tricentis: Automated Test Execution

This approach results in a true end-to-end digital validation platform: from the initial system definition through risk analysis to the final validation report—digital, traceable, and audit-ready.

What's already possible today—and what's next

The DHC Smart Validation Accelerator is not a future project. The following features are already in productive use in pilot projects with DHC customers:

Digitized Validation Management:
Complete Replacement of Paper-Based Processes
Automated Traceability Matrix:
Seamless linking of all validation objects
Automated Risk Matrix:
Risk overview of all processes and functionalities in use
Validation Objects with DHC Templates:
Structured, audit-ready documentation

Currently in the pilot phase:

Change Impact Analyzer:
AI-powered impact analysis based on release notes. The first production deployment is scheduled for SAP DM Release 26.11 in November.
Validation Content Generator:
AI-powered creation and updating of validation documentation
Tricentis Integration:
Orchestration of automated test execution directly from the SVA

Validation as a competitive Advantage

The key message is this: Validation in cloud environments doesn’t have to be a bottleneck. By using the right tools and processes, you can transform the validation effort from an obstacle to innovation into a true enabler.

Regulated companies that adopt digitized and automated validation early on reap multiple benefits:

Shorter validation cycles while maintaining the same level of quality
Audit-ready at any time – no need to manually gather documents
Scalability – new systems and releases are validated more efficiently
Future-proofing – the foundation for AI-supported validation processes has been laid

Conclusion

The cloud is fundamentally changing validation. Quarterly releases are no longer the norm: With SAP DM, for example, weekly hotfixes are also deployed—for instance, “SAP Note update” on Thursday, “deployment to Quality” on Friday, and “deployment to Production” on Sunday.

This reduces the time required for a complete revalidation to a single day. Anyone working at this pace with traditional document processes is at a disadvantage.

The DHC Smart Validation Accelerator, embedded in the SAP Digital Validation Platform, delivers exactly that: automation, traceability, and auditability throughout the entire system lifecycle.

→ Learn more about the DHC Smart Validation Accelerator
→ Learn more about validation of cloud systems

Would you like to make your public cloud validation more efficient and audit-ready?

DHC helps you design validation processes for public cloud and SaaS solutions in a structured, digital, and scalable way—from strategic assessment and toolchain selection to concrete implementation using the DHC Smart Validation Accelerator.

FAQs

Frequently asked Questions about Public Cloud Validation and
the DHC Smart Validation Accelerator

Why Do traditional Validation Approaches reach their Limits in Public Cloud Environments?

Because public cloud solutions are constantly changing at a rapid pace. Traditional, document-centric validation approaches are often too slow and too resource-intensive for short release cycles, tight testing windows, and recurring change impact analyses.

What is the DHC Smart Validation Accelerator?

Der DHC Smart Validation Accelerator ist eine digitale Lösung zur strukturierten Erstellung, Verknüpfung und Pflege von Validierungsartefakten. Er unterstützt Unternehmen dabei, Anforderungen, Risiken, Spezifikationen und Testfälle konsistent und auditfähig über den gesamten Lebenszyklus hinweg zu steuern.

What Benefits does the DHC Smart Validation Accelerator offer in Public Cloud Environments?

The DHC Smart Validation Accelerator helps reduce validation efforts, improve traceability, and conduct change impact analyses in a more targeted manner. This enables frequent changes in cloud environments to be assessed more efficiently and in a manner that meets regulatory requirements.

What Role does the Change Impact Analyzer play?

The Change Impact Analyzer helps evaluate new releases by analyzing which processes, documents, and test cases are affected by changes. This allows the required scope of testing and documentation to be determined in a risk-based manner and with significantly greater efficiency.

Which Companies will find this Article particularly relevant?

This is especially true for regulated companies in the life sciences industry that use public cloud or SaaS solutions such as SAP Digital Manufacturing and need to adapt their validation processes to more frequent changes.

Is the DHC Smart Validation Accelerator suitable only for SAP Digital Manufacturing?

No. SAP Digital Manufacturing is a clear use case, but the underlying challenges also apply to other public cloud and SaaS solutions in regulated environments. The DHC Smart Validation Accelerator is therefore relevant to a broader range of applications.

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