Stevens Institute of Technology Taps M-Files ECM and Part 11 Compliance Package for their Pharmaceutical Curriculum
May 7, 2012
University Integrates M-Files into Advanced Validation Course for Pharmaceutical Students
M-Files Inc., the developer of M-Files flexible cloud and on-premise enterprise content management (ECM) solutions, today announced that the Stevens Institute of Technology, a New Jersey-based university specializing in engineering, science, systems and technology management, is utilizing the M-Files Electronic Document Management System (EDMS) solution to provide FDA compliant management of Electronic Records and Electronic Signatures for documents students create during their course project in the “Contemporary Concepts in Pharmaceutical Validation” course in their Pharmaceutical Manufacturing and Engineering Program.
Stevens Institute of Technology is a premier private coeducational institution focused on research and entrepreneurship. The school was ranked as the nation’s third Top Patent-Revenue-Generating University by Forbes Magazine in 2008.
Stevens Institute is utilizing M-Files to teach pharmaceutical students at the university's Charles V. Schaefer, Jr. School of Engineering and Science about the documentation requirements associated with advanced validation and compliance processes. "The pharmaceutical industry is highly regulated and consequently creates an enormous amount of documentation. The paper-based systems that are used by many companies are highly inefficient and very prone to errors and losses of documentation. So it's vital that the next generation of professionals know how to effectively manage their documentation and information in order to comply with regulatory requirements, meet quality standards and bring products to market faster," said Andrew Walsh, Industry Professor at Stevens Institute of Technology.
Professor Walsh introduced his project-based advanced validation course in the Spring 2009 semester, which introduces students to the new regulatory directions, such as ICH Q8, ICH Q9, cGMPs for the 21st Century, Quality by Design initiative, PAT initiative and the then “draft” Process Validation Guidance from the FDA. The course is designed to provide students with a “hands-on” opportunity to learn the statistical techniques and risk management tools needed to implement the new guidance as well as gain experience managing the launch of a pharmaceutical product from start to finish.
"We needed an Electronic Document Management System (EDMS) that could easily handle the documentation requirements of the course project compliantly, yet was easy enough to use that it wouldn't take an entire semester for them to figure it out. I evaluated a few offerings, and it soon became clear that M-Files was the solution that best addressed our needs.” Walsh added “We are currently implementing the M-Files add-in for 21 CFR Part 11 compliance with Electronic Signatures. This will complete the package and put us on the same playing field as some major pharmaceutical companies that are using an EDMS".
"The Stevens Institute is renowned for producing the pharmaceutical leaders of tomorrow by arming them with the knowledge and practical skills to succeed," said Greg Milliken, president of M-Files Inc. "The integration of M-Files into the university's advanced validation and compliance curriculum reinforces how effective M-Files is for managing critical documentation processes and electronic records to ensure compliance with regulations and standards."
About Stevens Institute of Technology
Founded in 1870, Stevens Institute of Technology, The Innovation University™, lives at the intersection of industry, academics and research. The University's students, faculty and partners leverage their collective real-world experience and culture of innovation, research and entrepreneurship to confront global challenges in engineering, science, systems and technology management. Based in Hoboken, N.J. and with a location in Washington, D.C., Stevens offers baccalaureate, master’s, certificates and doctoral degrees in engineering, the sciences and management, in addition to baccalaureate degrees in business and liberal arts. Stevens has been recognized by both the US Department of Defense and the Department of Homeland Security as a National Center of Excellence in the areas of systems engineering and port security research. The University has a total enrollment of more than 2,350 undergraduate and 3,600 graduate students with almost 450 faculty. For more information, visit www.stevens.edu.
About M-Files Inc.
M-Files Inc. develops the award-winning M-Files enterprise content management (ECM) system and cloud-based service M-Files Cloud Vault that runs on the Windows Azure platform. M-Files is easy to deploy, learn and use, and has enabled thousands of businesses in over 90 countries make dramatic gains in efficiency and productivity by improving the way they organize and manage their business documents, information and processes. M-Files is available in 24 languages and is in use at customers such as AstraZeneca, EADS, Flybe Airlines and Parker Hannifin. For more information, visit us at www.m-files.com, the M-Files blog, and follow us on Facebook and Twitter.
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