Overview
Montrium’s SharePoint for Pharma is a series of collaborative workspaces and tools based on the Microsoft SharePoint™ platform, and focus on improving the management and tracking of GxP related activities. These workspaces provide pre-defined document and record management structures for regulated documents based on industry standards. In addition, standardized automated workflows aligned with standard operating procedures facilitate collaboration between operational teams whilst ensuring compliance. Montrium has a multitude of intelligent electronic forms based on InfoPath technology and GxP related document templates which are deployed within the SharePoint™ environment. Various lists and web based trackers allow teams to organize and use GxP data within process flows and forms. Finally, standardized dashboards and KPIs for each GxP workspace help transform your data in knowledge which in turn provides insight as well as a clear picture of real-time operations and performance.
Our approach is based on developing standardized fully documented and tested workspace templates that can be easily deployed within existing or new SharePoint™ environments. These templates are then adapted to the organizations processes and team structure. Through this approach Montrium is able to greatly reduce the time and cost required to implement such environments whilst ensuring the highest level of quality. Use of industry standards, as well as tried and tested practices, means that user adoption is seamless.
Montrium focuses on configuration and content development rather that software development and through its partnership with various vendors is able to provide an integrated environment for the management of GxP activities.
Through the integration of 3rd party solutions such as Arx CoSign Digital signatures and the development of specific enhancements, Montrium’s SharePoint for Pharma is able to meet the requirements of 21 CFR Part 11. Please request our white paper on how we meet 21 CFR Part 11 requirements for more details.
