Hosted, Secure and Validated SharePoint Records and Quality Management Solution for the Life Sciences
Overview
Montrium Connect has been designed to meet the specific needs of Life Sciences companies who may not have the time, budget or internal resources to implement expensive electronic document or quality management systems.
Montrium Connect is an innovative web-based service that answers these challenges by providing fully functional and pre-configured SharePoint powered workspaces through a secure, validated cloud environment – all for one low monthly per-user fee. Montrium Connect workspace solutions can be deployed in a matter of days and are fully compliant with FDA 21 CFR Part 11 and Annex 11. The document libraries, forms, automated workflows, and digital signature capabilities of Montrium Connect are all designed to Industry standard and to enhance operational efficiency. In addition, Montrium provides a resource center with online training and user guides and has an experienced support and technical team on hand to help you with the management of your environment.
Why not escape the burden of managing IT and related compliance activities, and free your team to focus on collaborating more effectively with internal and with external partners?
Contact us today to see how easy and affordable it can be.
Licensing Model
Montrium Connect service is provided for a monthly per user fee. The monthly fee includes all hardware and software required to run the various workspaces you have selected. The fee also includes user support and managed services for the maintenance of your Montrium Connect environment. Because Montrium Connect is based on industry standards and best practices, there is no costly customization required as it can be used as is for the vast majority of organizations. As no customization is necessary there are no system setup costs, just one flat monthly fee. User packages start at 5 users, and fees become digressive as you increase the number of users.
Records Management Workspace
The standardized and validated Montrium Connect Records Management Workspace puts you in complete control of over 600 pre-defined document types as well as an extensive metadata standard. It allows you to view documents and records in multiple structures based on the TMF Reference Model, ICH E6 standards or internal SOPs.
Our Records Management Workspace consists of a predefined SharePoint 2010 configuration that can be used from day one to help you manage all documents and records electronically. Automated workflows manage your records lifecycle from draft to final status based on document type. Integrated FDA 21 CFR Part 11 compliant signatures and automatic PDF publishing facilitate the generation of compliant records.
Quality Management Workspace
The Montrium Connect Quality Management Workspace provides you with a standardized environment to manage the authoring, approval and distribution of your SOPs and other quality system documents. Records management functionality allows for electronic document approval and integration with the training module. Incident and Deviations Management, CAPA and vendor management are other integrated modules, which are available in the Quality Management Workspace. The Quality management workspace is composed of electronic InfoPath forms, workflows and dashboards that give insight into quality operations.
Validation and Documentation
Montrium provides a complete set of system and validation documents as part of your Montrium Connect environment. In addition to these standard system documents, Montrium also provides you with your own set of detailed configuration specifications as well as optional user acceptance test scripts which can be adapted to your specific user requirements and executed as proof that the system meets your intended use.
Resource Center
The Resource Center provides online information and resources to help you work with Montrium Connect. This includes online training materials and videos, form center, SOP templates, user support requests, online knowledge base and user forum.
Key Characteristics
- Fully validated, configured SharePoint environment
- Can be deployed within days
- Based on a per-user, per month fee
- Comes fully documented
- Configuration based on industry standards such as the TMF reference model
