SAP Consulting and Software Validation

Computer System Validation

Computer System Validation (CSV)

Validation of computerized systems in the pharmaceutical industry and medical devices

These days, computerized systems play a central role in the development and manufacture of pharmaceuticals and medical devices. If such a system is used in critical business areas, the company must provide documented proof in the context of a software validation that the system works according to predefined specifications and that this standard is also upheld during everyday operations.

In areas that are subject to public health authority regulations (GxP) such as the pharmaceutical industry and medical devices, quality is ensured through the validation of computerized systems (CSV) according to predefined industry standards (e.g. GAMP 5, FDA Guidelines, PICs). The term CSV covers various issues of validation and qualification of computer systems, from the software application to the IT infrastructure to the system control and auditing.

Since 1996, DHC has been involved in the validation of various, but especially complex computer systems, such as ERP systems, document management systems, Clinical Trial Software, LIMS, etc.

Our validation approach is methodical, process-oriented and risk-based. Here we focus on the Lifecycle Model (V-Model) for the latest version of GAMP, the ISO standards (such as ISO 13485) as well as the regulatory requirements of 21 CFR (Part 11, 820…) and the European authorities. However, even agile development methods (e.g. SCRUM) can be covered by our validation methodology.

As part of the validation, we simultaneously define the operational IT service processes necessary to achieve a valid state. We also consider the integration into an existing quality management system.

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).

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.

Header: ® Sergey Nivens –