Validation of SAP S/4HANA
- 30+ years of SAP and compliance experience
- Industry expertise in Life Sciences
- SAP Silver Partner
SAP S/4HANA Validation
SAP S/4HANA is the central platform for digital transformation for many companies in the pharma, biotechnology and medical technology industry. At the same time, SAP systems in the regulated environment must be operated and validated in accordance with GxP regulations, EU GMP, FDA requirements or ISO 13485.
The challenge: Modern SAP architectures with cloud services, continuous updates and integrated platforms are changing the requirements for traditional computer system validation.
Challenges in SAP S/4HANA Validation
New Operating Models and Hybrid System Landscapes
SAP S/4HANA can now be operated in different deployment models – on-premise, private cloud, public cloud or hybrid. At the same time, solutions from the SAP ecosystem such as SuccessFactors or Ariba extend the system landscape.
Modern SAP technologies are changing validation
New technologies such as Fiori Apps, mobile applications, Machine Learning or Cloud Services require adapted validation approaches. Traditional, purely document-based validation strategies are increasingly reaching their limits.
Modern SAP technologies are changing validation
New technologies such as Fiori Apps, mobile applications, Machine Learning or Cloud Services require adapted validation approaches. Traditional, purely document-based validation strategies are increasingly reaching their limits.
Process and Risk-based SAP S/4HANA Validation According to GAMP 5
The DHC approach to SAP S/4HANA validation is based on the ISPE GAMP® Guidelines. It follows a process and risk-based approach with the goal of reducing testing and documentation effort and focusing validation specifically on the critical aspects of business processes and the system. Requirements from various regulations (e.g. FDA CFRs, EU GMP Annex 11) and standards (e.g. ISO 13485) are taken into account.
The process model is part of the DHC Best Practice methodology and covers the complete system lifecycle. It consists of templates, standard operating procedures (SOPs), training materials and tools for validating SAP systems.
The validation methodology has proven itself in transformation projects and operations, and is equally supported by business departments and IT.
Efficient and Digitally Supported SAP S/4HANA Validation
Cloud technologies and shorter release cycles require significantly more frequent and efficient validation of SAP systems – traditional, document-based approaches quickly reach their limits.
DHC therefore combines risk-based validation according to GAMP®5 with standardized accelerators and digital tools that structure, accelerate and make validation processes audit-ready. These include the Digital Process Landscape (DPL), the IT Compliance Framework, field-proven validation documentation and the DHC Smart Validation Accelerator as part of an End-to-End Digital Validation Platform for SAP system landscapes.
DHC Accelerators and Tools
Digital Process Landscape (DPL)
The Digital Process Landscape (DPL) contains all processes of the digital core relevant to the value chain as well as industry-specific solutions from the SAP ecosystem and has been continuously and evolutionarily developed over the past 25 years. Two objectives are pursued:
- Use of functional content to create user requirements/user stories and the resulting functional specifications and
- Creation of a redundancy-free and harmonized structure for GxP-compliant operation of SAP S/4HANA.
IT Compliance Framework
The IT Compliance Framework was developed to ensure implementation, validation and GxP-compliant operation of SAP S/4HANA from day one. It contains best-practice validation processes, SOPs and templates optimally tailored to SAP projects, with the goal of secure implementation and operation. This is particularly important when planning, hosting, operating and supporting in the cloud or when outsourcing to a service provider. When using the IT Compliance Framework, timely re-validation of the SAP system during changes is guaranteed (Managed Validation Services).
Processes and SOPs are consistently and logically aligned, ensuring efficient and cost-effective operation throughout the entire lifecycle.
- All mandatory CSV activities and functions are defined in the framework.
- Based on GAMP®5 V-Model and GAMP®5 Operation GxP Systems
- Focus on systems supporting business processes
DHC Smart Validation Accelerator
For the digitalization of validation processes, DHC provides the Smart Validation Accelerator. The platform supports companies in efficiently structuring, automating and documenting validation processes in an audit-ready manner.
The Smart Validation Accelerator is part of the SAP initiative for an End-to-End Digital Validation Platform and integrates seamlessly into the SAP ecosystem, for example with SAP Cloud ALM and SAP Signavio.
→ More about the DHC Smart Validation Accelerator
More about SAP S/4HANA Validation?
DHC Consulting Services
- Regulatory requirements (GxP, data integrity)
- System architecture and integrations
- Transformation strategy and system landscape
- Risk classification according to GAMP 5
The complexity of SAP products has continuously increased in recent years. Beyond the digital core SAP S/4HANA, a digital toolbox has emerged that supports business departments with specialized applications (e.g. SuccessFactors, Ariba). Furthermore, different deployment options (on-premise, private cloud, public cloud) increasingly lead to hybrid system structures. This increasing variability must be accordingly considered in validation. Additionally, new technologies such as Machine Learning or Artificial Intelligence require a rethinking of traditional validation approaches.
Our consultants are happy to support you competently in the following areas:
- Fit-gap or inspection readiness analysis of your validation framework and SAP validation documentation (friendly audits / compliance checks)
- 21 CFR Part 11 & EU GMP Annex 11 assessments
- Data integrity assessments
- Development of remediation plans, e.g. adapting your risk-based validation strategy to new regulatory requirements
- Design of a validation strategy tailored to SAP systems and respective deployment options, considering the SAP Activate project methodology
- Software validation / IT compliance workshops
- Review/development of test strategies
- Development of data migration and verification strategies
- Coaching of QA / validation management
For the risk-based and economical execution of your SAP S/4HANA validation, we offer you the following services:
- IT infrastructure qualification: It forms the foundation for SAP validation. We ensure that your IT infrastructure components are qualified in an audit-compliant manner.
- Development of a cloud compliance framework for using SAP S/4HANA as Private Cloud Edition
- Prospective SAP validation: SAP systems and the business processes mapped on them are validated during implementation.
- Retrospective SAP validation: Productively used SAP systems and their mapped business processes are validated during ongoing operations.
- Turnkey implementation of SAP validation remediation projects for audit readiness.
- Validation of SAP Fiori Apps
- SAP software validation methodology: Framework with work instructions for SAP validation are created, implemented and trained.
- Content generation / creation of lifecycle documents (e.g. URS)
- Development of a digital validation platform based on SAP CALM and the DHC Smart Validation Accelerator including an efficient change management process
We validate either based on your CSV framework, develop a custom methodology with you, or bring our DHC Best Practice methodology. Our Validation Services include taking over all validation activities – from project management to document creation – and include:
- Design of validation strategy, plan and report
- Creation / review of lifecycle documents
- Requirement management and process mapping
- Project management
- Training management
- Test management
- Data migration and data verification strategies
- Change management
- Periodic review
- Supplier management
- Audits at suppliers and service providers
With our “Managed Services for Validation”, validation effort and costs can be reduced and made transparent. Depending on your situation, we offer service packages specifically tailored to your needs in the area of Managed Validation Services. These range from targeted support (Validation as a Service = VaaS) to full service packages.
Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. We draw on over 25 years of experience in this area.
Why DHC – Your Specialist for SAP S/4HANA Validation
- Over 30 years of experience in SAP validation
- Specialization in pharma, life sciences and medical technology
- Deep know-how in GxP, FDA, GAMP and ISO 13485
- Validation strategy based on SAP Activate
- Scalable best-practice methodology
- Tool-supported validation with the DHC Smart Validation Accelerator
SAP S/4HANA Validation
Would you like to strategically secure your S/4HANA transformation and integrate compliance from the start?
Trust through Experience
We are the specialist for all IT solutions in quality management, assurance and control based on SAP ERP.
“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 S/4HANA Validation
What impact does the transformation strategy have on validation?
The chosen transformation strategy – such as System Conversion (Brownfield), Landscape Transformation (Bluefield®) or New Implementation (Greenfield) – has a direct impact on the scope and approach of validation. Depending on the scenario, existing validation artifacts must be adopted, adapted or completely recreated.
How can validation effort be reduced during an S/4HANA transformation?
A risk-based validation approach according to GAMP®5 helps focus on business and compliance-critical processes. Standardized validation frameworks, pre-built process models and digital validation platforms can additionally reduce effort significantly.
How can it be ensured that the system remains audit- and inspection-ready?
A structured validation strategy ensures that requirements, risks, tests and documentation are traceably linked. This allows companies to demonstrate at any time during audits that the system is implemented and operated in a controlled manner.
What role do cloud technologies play in S/4HANA validation?
With cloud operating models and hybrid SAP landscapes, validation requirements are also changing. Continuous updates, integrations with cloud systems and new platforms require adapted validation strategies and more digitally supported processes.
How can validation be integrated into an SAP S/4HANA transformation?
Validation should be integrated into the transformation project early and closely aligned with the SAP Activate project methodology. This allows validation activities to be efficiently integrated into project phases such as design, test and go-live.
What role does validation play in the ongoing operation of SAP S/4HANA?
Validation does not end with go-live. Even in operations, changes, updates and new functions must be evaluated, tested and documented in a controlled manner to ensure long-term system compliance.
When should companies start their validation strategy?
Ideally already in the early planning phase of the S/4HANA transformation. An early-defined validation strategy helps reduce project effort, avoid risks and minimize later adjustments.
SAP S/4HANA Validation