Montrium has introduced a suite of regulated document collaboration and quality management applications designed for life science organizations of all sizes. Montrium Connect is a SharePoint-based quality, records and systems management suite of applications that enables organizations to access SharePoint applications at a lower total cost of ownership via the Microsoft cloud.
Powered by Microsoft’s Windows Azure and Office 365 platforms, Montrium Connect includes a preconfigured 21 CFR Part 11-compliant solution, full implementation and validation, a support structure and scalability. Two qualification guidelines, available on Montrium’s Website, show that these environments can meet the requirements of 21 CFR Part 11 and Annex 11. “These guidelines allow life science organizations to establish a qualification strategy for the use of these platforms for regulated applications,” said the regulatory and compliance specialist company.
The global pharmaceuticals, biotechnology and life sciences industry posted revenues of more than $1.1 trillion in 2011, according to Deloitte’s 2013 Global Life Sciences Outlook.
“The life sciences industry is embracing the flexibility and lower total cost of ownership that SaaS-based solutions such as Montrium Connect bring,” Paul Fenton, president and CEO of Montrium, said in a statement. “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.”
Montrium Connect will initially be available in three cloud-based deployment options—365, Fast Track and Enterprise—to meet the requirements of different-sized companies with a per-user/per-month pricing model. Connect 365 is the entry-level solution, based on the SharePoint Online platform, and offers basic online document collaboration and management for clinical and regulatory documents.
The fast track offering, hosted on Windows Azure, is multi-tenant and targeted at smaller organizations that require a comprehensive electronic document management software (EDMS) and entry-level quality management system (QMS) without a large up-front investment. The enterprise option, on Windows Azure, is a dedicated cloud environment suitable for companies that require a large number of users and customization of the Montrium Connect environment. Solutions, configurations and capabilities can be added as companies grow, said Montrium.