SAP S/4HANA VALIDATION

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

IT Compliance

SAP S/4HANA VALIDATION

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?


DHC CONSULTING SERVICES FOR SAP S/4HANA VALIDATION

Compliance Check

We draw up a fit/gap analysis of your GxP compliance on the basis of a friendly audit, and we evaluate opportunities and risks. The results are presented to you as a GxP compliance roadmap with recommendations for implementation, an estimate of effort and a rough schedule.

  • Fit/gap analysis of IT processes for software validation and for operating the system (particular focus on system usability with the complexity of S/4HANA)
  • Assessment of the validation scope required (based on the business processes to be supported by the system)
  • Development of a business case for GxP compliance
  • Assessment of risks and opportunities
  • Recommended measures for implementation/further development
  • Analysis of the level of support required (rough planning of the required resources, skill level of resources available internally in relation to CSV, scope and skill level of external resources required)
Validation Services

Our DHC validation services include the end-to-end handling of all validation activities, from validation management through to document creation. We can coach you and/or take responsibility for the design and implementation of validation activities. This also includes your vendor audits.

  • Creation of a validation strategy, the validation plan and the validation report
  • Coaching, planning and execution of prospective and retrospective validation projects, including test management planning and execution
  • Operational support for the creation of lifecycle documents
  • Support during test management
  • Operational support for the creation of test specifications, during the documented execution of tests
  • Review of validation documents
  • Qualification of the IT infrastructure and IT services
  • Risk management
  • Project team training
  • Training management as part of the project
  • Audits at vendors and service providers

In the process, we use materials and tools that we have developed on the basis of our long-standing validation and sector-specific experience. These give you a responsive and structured project process while ensuring cost-effectiveness is not neglected.
These include:

  • Policies and SOPs for the implementation of computer-aided systems
  • Policies and SOPs for the operation of computer-aided systems in a regulated environment
  • Templates
  • SAP process models
  • Best practice requirements (URS)

The SAP Solution Manager and the add-ons developed by DHC for Solution Manager (DocumentChange and Test Management) give you a framework that facilitates the paperless validation of your IT system. To this end, our preconfigured solution consistently implements the DHC validation method and closes GxP gaps in standard SAP functionality.

Managed Validation Services

We handle the task of maintaining GxP compliance for you, and carry out the duties normally performed by a Compliance Manager. You can focus on your core activities in IT, while we assume responsibility for IT validation work as a ‘contract validator’.

  • Change management
  • Periodic reviews
  • Implementation of other topics/requirements, including data integrityGDP complianceIDMP compliancecloud validation, etc.
  • Validation management
  • Formal and contextual document control
  • Document workflow tracking
  • Coaching for documentation, risk assessment, audits, IT changes, tests, etc.
  • Audit preparation
  • Audit execution
  • Monitoring of the effectiveness and continuous improvement of the Quality Management system (QM manual, processes, SOPs, etc.)

DHC – YOUR SPECIALISTS FOR SAP S/4HANA VALIDATION

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.

WHY CHOOSE DHC?

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.

  • Over 20 years of experience in SAP validation and implementation experience
  • Acknowledged sector expertise in pharmaceuticals/life sciences and medical technology
  • A wealth of expertise in regulatory requirements (GAMP, FDA, GxP, ISO 13485, etc.)
  • Proven DHC method while integrating with SAP Activate
  • Tool-driven S/4HANA validation with the SAP Solution Manager (DHC add-ons)
  • High level of knowledge transfer
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
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