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GxPi Ltd

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FDA Compliance

Product News: GxPi Launches Hosted e-Document Management System

For small to medium-sized life science companies

Published: Wednesday, May 12, 2010 - 12:38

(GxPi Ltd.: Nottingham, UK)– 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 organizations in the biotechnology, pharmaceutical, and health care 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 minimized, 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, minimizing 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 needed, both within the system via a Wiki and remotely from GxPi. Training can also be managed on GxPi’s compliant training platform, “x-train,” which can be hosted as well.

“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,” says Keith Williams, CEO of GxPi. “x-docs hosted provides the benefits of an installed eDMS without the significant financial investment and potentially long implementation times associated with an enterprisewide solution, enabling small to mid-size organizations to quickly get up and running with low capital outlay.”

For more information on GxPi and other simply compliant solutions visit www.gxpi.com.

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GxPi Ltd

GxPi makes regulatory compliance leaner, by providing products and services to the biotechnology, pharmaceutical, consumer health care, medical devices, and veterinary industries, that are “simply compliant”. GxPi’s services branch delivers high value and high-impact consulting which covers: all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, and GxP), qualified person (QP), quality assurance (QA), validation services (process engineering, computer systems, and laboratory equipment), clinical technology, training, and project management. GxPi’s solutions branch provides electronic document management solutions (eDMS) to the life sciences sector via the “x-docs” platform. x-docs is a new class of document management software which is powerful and practical in enabling sponsors and contract research organizations to comply with increasing regulatory requirements. x-docs is easy to configure, requires little IT support, is cost effective for organizations of all sizes, and entirely intuitive to use with minimal training.