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Clinical Research Organization Utilizes M-Files ECM for FDA 21 CFR Part 11 Compliance; Integrates M-Files into SharePoint and Dynamics SL
M-Files Inc., the developer of M-Files cloud, on-premise and hybrid enterprise content management (ECM) solutions that manage information by what it is versus where it's stored, today announced that MedTrials, Inc., a contract research organization (CRO) that provides clinical development services to pharmaceutical, biotechnology and medical device companies, has deployed M-Files to manage clinical trial documentation and processes and to help ensure compliance with FDA CFR Part 11 and other applicable business and industry regulatory requirements.
MedTrials specializes in the planning, execution and analysis of clinical trials ranging from small, focused studies to complex, multinational projects. The company required a document management and workflow solution that could meet not only its operational business needs, but also enable it to efficiently organize and manage its large volume of regulatory documents so that they are indexed and easily retrievable in digital form.
MedTrials is leveraging M-Files to reduce document cycle time and simplify information management by automating document routing, notification, versioning and approval processes. With complete version and history preservation, automatic backup, role- and team-based rights administration, status-based workflow capabilities and time-stamped audit trails, M-Files gives MedTrials the ability to enforce the specific processes associated with their business and clinical practices.
"Prior to M-Files, we were using an on-premise document management system that did not adequately scale to support the diversity of technical services we provide and allow efficient access to, and dynamic management of, the wide range of document types that our staff and clients use, modify and share. We needed a solution that would give us comprehensive control of our quality documents and processes in order to help us meet regulatory compliance requirements as efficiently as possible," said Brian Morgan, Chief Operating Officer at MedTrials. “We evaluated other ECM solutions, but they were either too complex or specialized, and often did not offer the support for FDA 21 CFR Part 11 that we needed. With M-Files, we have a unified document control foundation for compliance that ensures process quality and reduces risk.”
MedTrials is expanding its use of the electronic signing and compliance support capabilities in M-Files to create a more efficient system for the review of clinical trial documentation, which will allow the company to continue to improve their cycle times for document routing and approval.
“Our corporate infrastructure document management needs were our first priority as we implemented M-Files across our office locations,” noted Lynn Van Dermark, Chief Executive Officer at MedTrials. “From that foundation, we then migrated our Quality Management System (QMS) documents (controlled and versioned policies and procedures, change control documentation, and related records) into M-Files, and developed an electronic trial master file (eTMF) capability to allow real-time access by our service teams and clients to clinical trial documentation while assuring document security and integrity.”
Automated enforcement of policies, reporting, e-signature support and full audit trails have streamlined how MedTrials maintains compliance with 21 CFR Part 11.
"With M-Files, our workflows have become much more efficient and transparent because we can now set assignments and confirm everyone has completed their required tasks," added Jeremy Weaver, Network Systems Administrator at MedTrials. "M-Files enables us to accomplish much more than just managing documents -- it helps us maintain compliance with industry standards and provides us with greater control over the quality processes involved."
"In order to effectively manage their clinical trial information and processes, MedTrials required a document and enterprise content management solution that enabled them to integrate people, tasks, documents and processes to efficiently manage processes and monitor trial performance. M-Files provides MedTrials with a platform for effective document control and process management by streamlining and automating document-centric workflows, promoting efficiency and simplifying compliance," said Greg Milliken, president of M-Files Inc. "M-Files enables MedTrials to systematize and automate documentation reviews and approvals, significantly reducing their risk of noncompliance while providing 100% traceability of mission-critical regulated documents."
Integration with SharePoint and Dynamics SL a Key Consideration for Deploying M-Files
MedTrials leverages SharePoint as its company-wide collaboration platform and uses Dynamics SL as its backend accounting system, so it was vital for their document management solution to integrate seamlessly with both of these core business systems. With M-Files, MedTrials has quick and convenient access to a full-range of document management capabilities directly from within their SharePoint and Dynamics SL platforms, making access to important documents and participation in workflows seamless and easy for its staff, which has had a profound impact on the successful company-wide adoption of the solution.
"MedTrials considers document management to be one of our highest organizational priorities, and we needed to look beyond SharePoint for expanded capabilities. A key factor in us deciding to go with M-Files is that it enables us to integrate powerful, out-of-the-box document and business process management functionality with SharePoint’s collaborative capabilities," said Randy Crawford, Vice President for Business Operations at MedTrials.