Validation of IT-Systems
Methodical, process-oriented and risk-based validation approach for software validation
Since 1996, we have been gaining experience in the prospective and retrospective validation of various complex computer systems, such as ERP systems, document management systems, clinical trial software, LIMS, etc. We analyze the GxP requirements that are relevant for you and pragmatically specify the measures you will need to take based on risk analyses. Here, DHC distinguishes itself not only with an excellent knowledge of IT systems, but also through expertise in project and process management as well as a deep industry experience in the life sciences (particularly pharmaceuticals and medical devices).
DHC provides a uniform, methodical, process-oriented and risk-based validation approach (DHC’s Simple Validation Services). We base this approach on the V-model from the latest version of GAMP, the ISO standards and FDA requirements (particularly 21 CFR Part 11) and the European authorities (in particular EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers and meets all the criteria for optimal costs and benefits. We also allow for integration into an existing quality management system.
- Knowledge of policies and long-term experience in the validation of various applications
- Templates, SOPs to be able to perform an efficient validation
- Assistance in designing and implementing a validation framework
- Support in specific projects (validation management, operational support, coaching, …)
DHC Validation Method “DHC’s Simple Validation Services”
With our Simple Validation Services, DHC provides you with a proven process and risk-based approach based on a unique methodology for the pharmaceutical industry and medical devices (“Validation Concept”) which is constantly being updated. Our approach is clearly scalable and thus easily adapted to the respective industry and company requirements.
When implementing the project (“Project Execution”), our experienced consultants work according to the lifecycle model (V-model).
At the beginning of every successful validation is the detailed planning: In the design phase, the technical specifications are drawn up and risk analyses are carried out. In the design review, you determine whether all user requirements have been implemented in the specifications and whether all points were evaluated for GMP risk. After the implementation the test phase begins, followed by the verification and the release if applicable. When the required documentation has been verified, the validation is complete.
Based on our many years of validation and industry experience, we have developed best practices for you, such as SOPs, templates, SAP Business Processes and SAP URS. This gives you a fast and structured project schedule and provides the desired cost effectiveness.
Support tools, such as SAP Solution Manager, provide computerized documentation, change and test management. With the process management tool DHC Vision, we offer a solution for process-oriented validation based on the DHC reference processes.