SAP Cloud Validation
- 30+ years of SAP and compliance experience
- Industry expertise in Life Sciences
- SAP Silver Partner
Validation of SAP Cloud Systems
Cloud-based SAP solutions are becoming increasingly important in regulated industries as well. Applications such as SAP Ariba, SuccessFactors, SAP Analytics Cloud or SAP Business Technology Platform extend the digital core SAP S/4HANA and support central business processes.
However, cloud and SaaS solutions pose new requirements for compliance, change management and auditability – for example through continuous updates, shared responsibilities between provider and operator, and hybrid system landscapes.
DHC supports you in validating SAP cloud systems efficiently and in a regulatory-compliant manner while enabling the operation of modern SAP system landscapes.
Challenges in the Validation of SAP Cloud Systems
Continuous Updates and Release Cycles
Cloud-based SAP systems are regularly updated. Validation and change control must therefore work reliably even with frequent releases.
Shared Responsibilities in Cloud Operations
With SaaS solutions, provider and operator share system responsibility. Roles must be clearly defined for GxP-compliant use.
Hybrid SAP System Landscapes
SAP S/4HANA is frequently combined with various cloud solutions. Validation must therefore also consider integrations and data flows.
Risk-based Cloud Validation Strategy
Cloud systems follow different rules than traditional on-premise systems. Continuous updates, SaaS operating models and shared responsibilities between provider and operator fundamentally change the requirements for computer system validation. Validation becomes a continuous compliance process closely integrated with release, change and operational processes.
DHC supports companies in establishing a cloud CSV strategy that meets regulatory requirements while enabling the secure operation of modern SAP system landscapes.
The focus is on:
- Clear responsibilities between provider and operator
- Release and change management for continuous updates
- Adapted test strategies for cloud systems
- Integration into existing CSV and IT compliance processes
- Audit-ready documentation and inspection security
Typical SAP Cloud Systems in the Regulated Environment
In addition to SAP S/4HANA, many companies rely on additional cloud solutions from the SAP ecosystem.
Typical examples include:
- SAP Ariba – Procurement and supplier management
- SAP SuccessFactors – HR and training management
- SAP Integrated Business Planning (IBP) – Supply chain planning
- SAP Analytics Cloud – Reporting and analysis
- SAP Signavio – Process management
- SAP Business Technology Platform (BTP) – Extensions and integrations
- SAP Cloud ALM – Application Lifecycle Management
- SAP Digital Manufacturing – Production control
When these systems support GxP-relevant processes or data, they must be validated accordingly.
More about SAP Cloud Validation?
Digitalization of SAP Cloud Validation with the DHC Smart Validation Accelerator
To accelerate and digitalize validation processes, DHC developed the DHC Smart Validation Accelerator, a modern validation platform that significantly increases the efficiency of validation processes through the use of Artificial Intelligence (AI) and full integration into the SAP ecosystem with SAP Cloud ALM and Tricentis.
Why DHC – Your Specialist for SAP Cloud System Validation
- Over 30 years of experience in SAP validation and GxP compliance
- Expertise in cloud, SaaS and hybrid SAP environments
- Validation based on SAP Activate and best practices
- Efficient, tool-supported implementation with the DHC Smart Validation Accelerator
- Focus on compliance, data integrity and auditability
SAP Cloud System Validation
Trust through Experience
We are the specialist for all SAP Life Sciences solutions.
“We have successfully completed various (large-scale) projects in the validation environment together with DHC. The extremely competent consulting combined with a great working relationship form a more than convincing overall package. This makes DHC a strong partner that we will gladly continue to rely on in the future.”
“DHC developed a brilliant concept for SAP validation for mid-sized companies at our site in 1997. I can still endorse that even after 2 decades of practical implementation experience.”
Frequently Asked Questions about SAP Cloud Validation
Are cloud systems even GxP-capable?
Yes. Cloud-based systems can generally be operated in a GxP-compliant manner, provided regulatory requirements for data integrity, traceability and controlled changes are met. What matters is not the operating model itself, but clear governance over responsibilities, validation, change management and documentation. Companies must ensure that cloud systems are integrated into their quality management and compliance framework and that operations can be demonstrated to be audit-ready at all times.
How does the cloud change the responsibility for GxP compliance?
Even when using cloud or SaaS solutions, the company remains responsible for the GxP-compliant use of the systems. While the provider delivers infrastructure and operations, companies must ensure that processes, data and system usage comply with regulatory requirements.
What risks arise when cloud systems are not validated in a structured manner?
Without a structured validation strategy, risks can arise, such as lack of traceability of changes, insufficient test coverage or unclear responsibilities between provider and operator. This can lead to compliance deviations during audits or inspections.
How do cloud updates affect the audit readiness of a system?
Cloud providers regularly deliver updates and new features. Companies must therefore ensure that changes are evaluated, tested and documented. Structured release and change management is crucial to ensure long-term auditability.
What role does a cloud CSV strategy play for hybrid SAP system landscapes?
Many companies today operate hybrid landscapes of SAP S/4HANA and various cloud solutions. A cloud CSV strategy ensures that validation, compliance processes and documentation are consistently implemented across all systems.
How can validation effort be reduced for cloud systems?
A risk-based approach helps focus on business and compliance-critical processes. At the same time, automated tests, structured validation data and digital validation platforms can significantly reduce effort.
What role does data integrity play in cloud systems?
Data integrity is also a central component of regulatory requirements in cloud environments. Companies must ensure that data is stored completely, consistently and traceably and is auditable at all times.
When should companies develop a cloud validation strategy?
A cloud CSV strategy should be developed when introducing new cloud systems or platforms. This allows validation processes to be defined early and avoids later adjustments or compliance risks.
How can cloud systems be integrated into existing CSV frameworks?
Cloud systems should not be viewed in isolation. They must be integrated into existing validation frameworks, IT governance processes and quality management systems to ensure a consistent compliance strategy across the entire system landscape.
SAP Cloud System Validation
Are you planning to deploy SAP cloud solutions and want to ensure that your systems are operated and validated in a GxP-compliant manner?