Village Gamer

Regulatory and compliance specialist Montrium has announced the release of Montrium Connect on the Microsoft cloud. Montrium’s Windows Azure-based offering is designed for companies who are looking to respond to the ever changing and demanding needs of the Life Science Industry. Montrium’s significant industry knowledge and expertise coupled with its understanding and commitment to technological innovation has enabled us to develop solutions that can suit any Life Science organisation, large or small.

Montrium Connect, a SharePoint based quality, records and systems management solution designed specifically for the Life Sciences allows organizations to leverage a fully configured solution in a fraction of the time normally associated with traditional on-premise solutions. Powered by the qualified Windows Azure and Office 365 platforms, Montrium Connect includes a pre-configured 21 CFR Part 11 compliant solution, full implementation & validation, a strong support structure and complete scalability, all packaged into one easy to manage per user / per month pricing model.

“The life sciences industry is embracing the flexibility and lower total cost of ownership that SaaS based solutions such as Montrium Connect bring,” said Paul Fenton, President & CEO of Montrium. “We are able to deliver a fully validated, configured and operational environment for all sizes of organization in a matter of days, which is a significant game changer for the industry who in the past have had to wait months for the deployment and validation of traditional EDMS and QMS systems.”

Initially, Montrium will be offering three product options, designed for companies of different sizes and with different needs:

• 365 – entry level Connect 365 solution is based on the SharePoint Online platform and offers basic online document collaboration and management for clinical and regulatory documents.
• Fast Track – Montrium’s fast track solution, hosted on Windows Azure, is multi-tenant and targeted towards smaller organizations that require a comprehensive EDMS and Entry Level Quality Management System without a large upfront investment.
• Enterprise – Montrium’s Enterprise deployment option, also on Windows Azure, is a completely dedicated cloud environment typically suited to companies requiring a larger number of users and who want to be able to customize their Montrium Connect environment.

The Microsoft Windows Azure and Office 365 platforms have enabled Montrium to partner with Microsoft to provide our solutions in an extremely scalable, secure, compliant and cost effective environment. Montrium has demonstrated that these environments can meet the requirements of 21 CFR Part 11 and Annex 11 in two qualification guidelines which are available on our website. These guidelines allow Life Science organizations to establish a qualification strategy for the use of these platforms for regulated applications.

Andrea McGonigle, Managing Director of Life Sciences at Microsoft said, “It is extremely encouraging to see service offerings such as Montrium Connect leverage the power of the Microsoft cloud. Montrium has implemented an innovative service model that will significantly facilitate access to regulated SharePoint applications for all types of Life Science organizations at a significantly lower total cost of ownership.”

Through the development of this innovative product offering, Montrium has enabled companies of all sizes to be in control of their regulated processes. Solutions, configurations and capabilities can be added over time allowing our clients to grow their environments as their business grows.