SAP Consulting and Software Validation

SAP Validation

SAP Validation

Methodical, process-oriented and risk-based approach for a prospective validation of SAP

ERP systems in a regulated environment must be operated in accordance with regulatory requirements. Therefore, if SAP is used in a GxP-regulated environment, then the system must be validated in accordance with the applicable laws and guidelines (e.g. AMG, 21 CFR Part 11, EC GMP Guide Annex 11…). Validation provides documented and reproducible proof that the system meets the pre-specified requirements.

Based on almost 20 years of validation and industry experience in the life sciences (in particular with the pharmaceutical industry and medical devices) we have developed a methodical, process-oriented and risk-based approach for prospective validation of SAP (“DHC’s Simple Validation Services”). Our approach is based on the lifecycle model (V-model) of the current GAMP industry standard in compliance with the ISO standards and legal requirements, such as 21 CFR Part 11 and 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 achieve additional efficiency through our reference models (over 150 modeled processes), templates and SOPs, which have been accrued from the implementation of numerous validation projects.

Because of our expertise in SAP implementation, we can offer an integrated approach for the validated and quality-assured implementation of SAP systems.

With our Simple Validation Services, DHC provides you with a proven process and risk-based approach based on a constantly updated unique methodology for the pharmaceutical industry and medical devices (“Validation Concept”). 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).

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.

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.

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