Regulatory compliance expert, GxPi, has introduced its 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 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.
The software 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 can be managed on the compliant training platform, X-train, which can also be hosted).