SAP S/4HANA VALIDATION

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)

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 (Document, Change 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.

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 integrity, GDP compliance, IDMP compliance, cloud 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.)