Our software solution ConSense GxP was developed especially for validation management and quality management in regulated companies. Before using a computer-aided system or software as part of quality management in a regulated company, a computer system validation or software validation is usually required.
For this reason, we deliver the prevalidated ConSense GxP standard software solution.
This means that it provides documented proof that it complies with the applicable GxP regulations and the reproducible fulfilment of the pre-specified requirements in practical use.
ConSense GxP's qualification as well as technical and content software validation take place in the operating environment of the user's company and in connection with the overall system. Based on the recommendations of the GAMP 5 Guidelines for the Validation of Computer-Aided Systems, software validation is performed according to the V-Model, an established procedure for implementing IT projects. According to this proven model, validation takes place in several project phases, which are accompanied by detailed documentation.
On request, we accompany the software validation as advisors and collaborators. Our range of services includes support for software validation concerning validation planning and the entire validation documentation. Our experts draw from extensive experiences from numerous implementation projects and validations of ConSense GxP.
Do you have questions about software validation or are you interested in ConSense GxP? Then feel free to contact us.