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.
- Policies and SOPs for the implementation of computer-aided systems
- Policies and SOPs for the operation of computer-aided systems in a regulated environment
- 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.