Regulatory compliance experts GxPi announce the availability of its leading Electronic Document Management System (eDMS) x-docs as a hosted software service. x-docs hosted enables small and medium sized organisations in the biotechnology, pharmaceutical and healthcare industries to easily create, manage and store, controlled and regulatory documents without the set up, project time and cost typically associated with a full client/server software installation. Companies can implement x-docs hosted in two to eight weeks and can add users and enrich functionality as the business grows.
With x-docs hosted, all Microsoft Client Access and x-docs user licenses are paid for on a monthly basis. x-docs eDMS is built on Microsoft’s prolific SharePoint platform and incorporates an enhanced document management layer which is specifically configured for validated environments. The hosted software is accessed remotely via a secure Internet connection and documents are stored on GxPi’s validated servers. Deployment and installation time are significantly reduced and capital expenditure is minimised, as well as the administrative costs.
x-docs hosted includes an enhanced audit capability, integrated compliant electronic signatures and password management, to ensure regulatory compliance, including FDA 21 CFR Part 11 guidance on electronic signatures and records. User interface and document upload is simple to understand and requires no specialist knowledge, minimising training time and support interventions. x-docs hosted also includes access to GxPi’s standard templates of regulatory and validation document libraries and protocols, further easing the transition from a paper-based system to an eDMS. Training and support can be accessed easily as required, both within the system, via a Wiki and remotely from GxPi (training even be managed on our compliant training platform, x-train, which can also be hosted).
“Small and mid-sized companies within the life sciences industries are looking for ways to comply with regulations governing document management, but the cost involved in traditional software installations can be prohibitive,” comments Keith Williams, CEO, GxPi. “x-docs hosted provides the benefits of an installed eDMS without the significant financial investment and potentially long implementation times associated with an enterprise wide solution, enabling small to mid-size organisations to quickly get up and running with low capital outlay.”
This article was published in Drug Discovery & Development magazine: Vol. 13, No. 4, May 2010, p. 8.