GxP Compliance with the End-to-End Digital Validation Platform (DVP)
The digitalization, modularization, and cloudification of the SAP system landscape challenge companies in regulated environments to make their validation processes more efficient, consistent, and auditable. The “End-to-End Digital Validation Platform” is a joint initiative by SAP and its partners DHC, Tricentis, and P36.
Die Initiative im Kontext der digitalen Transformation
SAP is accompanying companies in the transition from monolithic ERP systems to modular, cloud-based architectures with the SAP Business Suite and its Business Technology Platform (BTP) as the technological foundation. To support this, SAP has developed an integrated toolchain, a standardized framework and expert consulting. This is aligned with the SAP Activate methodology (Discover to Run). For the regulated environment, however, auditability and compliance must also be built in from the ground up.
SAP recently introduced the Business Data Cloud, which connects important data, consolidates it across business areas and supports industry-specific processes through SAP and partner solutions. Every business area benefits from intelligent agents that enable end-to-end processes through orchestration, from finance to demand forecasting and for end users.
The End-to-End Validation Platform initiative focuses on the value chain in life sciences. Compliance must be integrated at every stage, from procurement to field sales representatives.
In regulated industries such as life sciences, this means: validation must also be rethought, risk-based, orchestrated, documented and embedded in the processes.
This is precisely where the initiative comes in. The goal is to provide a seamless and future-proof validation platform with open APIs, partner integration and native cloud services, covering not only SAP’s own applications but also extensions and integrations.
In the validation of computerized systems, SAP focuses on the following pillars:
- the integration and orchestration of IT and validation processes via Cloud ALM,
- validation management via the DHC Smart Validation Accelerator,
- Enterprise Architecture Management with identification of GxP-critical applications in LeanIX (inventory),
- process management via Signavio,
- test automation via SAP Test Automation (Tricentis) and
- enablement via WalkMe.
SAP’s vision is to ensure that validation tools are integrated into platforms such as SAP Cloud ALM.
Partner Solutions Working Together
DHC contributes the DHC Smart Validation Accelerator (SVA), a platform that allows validation requirements to be documented directly in the system. Electronic signatures, audit trails and structured approval processes ensure compliance. At the same time, DHC accelerates validation projects through pre-built templates and workflows, and above all through the integration of validation into the Cloud ALM-based implementation following the Activate methodology.
The traceability matrix from user requirement to test is automatically generated from the validation data, so that the validation manager has visibility of all open items. Validation planning, risk analysis and collaboration with other initiative partners are part of the approach. The goal: faster cloud deployment and change management with a robust validation process.
Tricentis supports automated test execution and GxP-compliant approval processes with its Tosca and Vera solutions. Individual approval chains with electronic signatures and audit-proof data storage enable continuous validation. Everything is traceable, signed and securely stored. The goal: supporting automated, traceable and compliant validation workflows from start to finish. Even if customers use other tools, open APIs enable deep integration, making this model extensible rather than exclusive. Everything is cloud-native and supports a clean core strategy.
P36 addresses a central challenge of cloud-based platforms such as SAP BTP: the qualification of services and extensions. Since BTP is a public cloud platform, a static one-time qualification is not sufficient. P36 offers a combination of initial and continuous qualification, where risk-based test procedures are carried out on a regular basis. P36 offers these tests as a service.
This model has already been adopted by SAP and other GxP-regulated organizations.
An orchestrated, open system with SAP Cloud ALM
SAP Cloud ALM forms the backbone of the initiative. It provides the orchestration of requirements, workflows, tests, and releases. Through the integration of partner solutions, a validation landscape emerges that follows the GAMP 5 phases, from specification to re-validation.
Open APIs ensure flexible extensibility, allowing existing tools to be integrated as well. Compliance is thus not just enabled but actively shaped.
Outlook and Conclusion
The initiative pursues three central goals:
- Compliance by Design, end-to-end and auditable
- Automation and acceleration of validation processes, in projects and in change management
- Readiness assessment for cloud migration and ALM modernization
The close collaboration between SAP and DHC, Tricentis, and P36 lays the foundation for a new era of digital validation. Companies in the life sciences industry are invited to discuss their individual requirements in readiness workshops.
Visit our → Web sessions on the End-to-End Digital Validation Platform (DVP).
End-to-End Digital Validation Platform (DVP)
Feel free to contact us for further information, demos, or to participate in pilot projects.
