DHC validation method for SAP S/4HANA
based on SAP Activate

GxP Compliance


Since 1996 we have been supporting companies in the life sciences industry (pharmaceutical and medical technology) worldwide as industry experts in the implementation and further development of their SAP systems. Thanks to our expertise in the areas of business processes, SAP and IT compliance, we are now the leading consulting firm in the German-speaking world for the validation of SAP systems.

Over the years, we have developed a cost-efficient validation approach for SAP products that is scalable, risk-based and process-oriented.

The validation focus is directed to the critical aspects of the processes and the system. The method has proven itself both in the project and in operation, and is supported equally by the business department and IT. The process model is part of the DHC Best Practice Method and also consists of work instructions (SOPs), templates, training materials and tools for software validation and especially for the validation of SAP systems. It covers the complete system lifecycle from initial implementation, through the operational phase to decommissioning and data archiving



With SAP S/4HANA, SAP has launched a new generation of its enterprise software that is intended to make companies fit for the challenges and opportunities of the digital future. But what does this new technology mean for companies in a regulated environment, who need to operate and validate the system in accordance with the valid laws and directives (e.g. EU GMP, FDA, ISO 13485:2016)?

  • And how is this affected by the choice of the transformation strategy? (New implementation – or system conversion?)
  • How can the SAP Activate project methodology be reconciled with your validation method?
  • How should the trend towards increasing mobility and the use of Fiori apps be handled?

  • Is deployment of the SAP S/4HANA cloud an option in a regulated environment?
  • How does the SAP Solution Manager provide support for life-cycle documentation?


Compliance Check & Strategy

The complexity of SAP products has increased continuously in recent years. In addition to the digital core SAP S/4HANA, a digital toolbox has been developed, which supports the departments with specialized applications (e.g. S /4HANA, Success Factors, Ariba) according to their requirements. Furthermore, various deployment options (on premise, private cloud, public cloud) are increasingly leading to hybrid system structures. This increasing variability must be taken into account accordingly in the validation. In addition, new technologies such as machine learning or artificial intelligence require a rethinking of traditional validation approaches.

Our consultants are happy to provide you with competent support in the following topics:

  • Fit-Gap or Inspection Readiness Analysis of your validation framework and your SAP validation documentation (Friendly Audits / Compliance Checks)
  • 21 CFR Part 11 & EU GMP Annex 11 Assessments
  • Data Integrity Assessment
  • 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 the respective deployment option, taking into account the SAP Activate project methodology
  • Development of a paperless validation platform based on SAP Solution Manager including efficient IT service management processes
  • Software validation / IT compliance workshops
  • Development of test strategies
  • Development of data migration and verification strategies
  • Coaching of QA / validation managers
Validation Services

The core of our Validation Services is the risk-based and economical execution of the validation of your SAP systems. We are also happy to provide you with our DHC Best Practice Method. We offer the following implementation services:

  • IT Infrastructure Qualification: It forms the foundation for SAP validation. We ensure that your IT infrastructure components are qualified in accordance with the audit.
  • Prospective SAP validation: SAP systems and the business processes mapped on them are validated during implementation.
  • Retrospective SAP validation: SAP systems in productive use and the business processes mapped to them are validated during operation.
  • 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.

We either validate on the basis of your work instructions, work out your own method with you or have our DHC Best Practice Method in our luggage. Our Validation Services include taking over all validation activities – from project management to document creation – and include

  • Concept of validation strategy, plan and report
  • Creation / Review of Life Cycle 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 of suppliers and service providers

Managed Validation Services

With our <strong>”Managed Services for Validation”</strong> the effort and costs of IT Compliance can be reduced and made transparent. Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer requirements. These range from targeted support (Validation as a Service = VaaS) to a full service package

Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. In doing so, we rely on more than 20 years of experience in this area



Based on our more than 20 years of SAP ERP experience and the proven validation method for SAP ECC, we have developed a completely new SAP S/4HANA implementation and validation method for the pharmaceutical industry and medical technology with the “CSV Compliance built-in Approach”. This combines the best of both worlds – a process-oriented project and system documentation according to GAMP and 4Q model as well as the SAP Activate project approach with its accelerators and best practice processes (SAP Solution Manager).
The DHC add-ons for SAP Solution Manager provide computer-aided document, change and test management for S/4HANA validation.

The method is clearly scalable and therefore easy to adapt to the respective industry and company requirements. It meets all the criteria of a cost- and benefit-optimized procedure for validating S/4HANA.


Mohammad Anwar Hossain, Project Manager, SAP project ‘UTTORON’, Deputy General Manager, IT, Incepta Pharmaceuticals Ltd., Dhaka

“DHC made the most effective job in our project. Many of their activities not only assured the goal of a prospective validation of SAP ERP ECC 6.0, but also reduced the project risk. Due to the structured approach with SAP processes and business scenarios and defining the business requirements in URS documents, we were pretty sure, that the new ERP system will cover the daily business of Incepta.”


Work side-by-side with us to develop the right validation strategy for your S/4HANA transformation, and benefit from the new DHC validation approach based on SAP Activate.

Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0

Matthias Bothe, DHC GmbH
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7

Carsten Buri, DHC AG
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Learn more about our consulting services for S/4HANA validation!



28. Januar
Web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The webinar looks at the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

04. Februar
Web session (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of p36

10. Februar
Web session (in German)

Your journey to the secure Microsoft Cloud for Pharma, Medical Technology and Biotech

Overview of the key success factors for security on the path of regulated companies to the Microsoft Cloud

11. Februar
Web session (in German)

New ISPE GAMP® Good Practice Guide: Enabling Innovation

What does the new ISPE Guide mean for Computer System Validation (CSV) or Computer Software Assurance (CSA)?

18. Februar
Web session (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

10. März
Web session (in German)

SAP S/4HANA Implementation and Validation in Life Sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.


Our webinars are provided as a free service for DHC customers and potential customers.