At GXPi we have developed a range of products specifically for the Life Sciences sector focused on streamlining compliance processes to deliver both ergonomic functionality and long term cost savings.
Our product suite is centred on our enterprise X-docs™ platform. The products are built with compliance principles in mind, designed to meet regulations such as 21 CFR part 11 and EU Annex 11, and based on the best-selling Microsoft SharePoint platform (Foundation version). The configured document management modules are complemented by X-train™ to enable the integration of a compliant training platform to resolve the traditional problems of paper based training systems. X-forms™ is a new and flexible extension to the X-docs™ platform enabling the configuration of a range of forms based processes such as Change Control, CAPA, Deviations, Out of Specifications and Audit setup/findings.
Modular and configurable by design
With a range of preconfigured modules which can be deployed directly for a rapid implementation or used as an accelerator to base client specific configurations on the X-docs™™ products are ideally suited to getting up and running in a fraction of the time used in a conventional design and build EDM project. Modules may be mixed and matched to suit the business areas involved, take a look at examples for the Quality/Manufacturing or the R&D/Clinical areas and see how X-docs™ could help solve your content and process related problems.
GXPi’s SharePoint for Life Sciences
GXPi have taken standard SharePoint functionality and configured and enhanced it to deliver Enterprise Content Management (ECM) compliant with the requirements of the FDA and EMA regulations for Pharmaceuticals. This approach utilises the best features of SharePoint to underpin advanced ECM functionality necessary to meet the stringent requirements in the Life Sciences and Pharmaceutical industry. Specifically we have incorporated a lifecycle state machine and supplemented the audit trail to achieve compliance. Our experienced staff can provide information about what is possible in SharePoint and X-docs™, capture your document and content requirements and quickly configure sites, test and validate using tried and tested project management and delivery methodologies with our product suite.