SAP S/4HANA VALIDATION

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

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

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