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MasterControl Provides Industry Guidance with White Paper on eTMF Management Essentials

June 13, 2017

SALT LAKE CITY, UT, UNITED STATES - Jun 13, 2017 - MasterControl, a leading global provider of enterprise quality management systems (EQMS) and quality consulting services, today announced the release of a new white paper, “eTMF Management Essentials.” MasterControl developed the white paper as part of its ongoing efforts to help the industry better understand and align their processes with evolving technologies, the increasing focus on transitioning from paper trial master files (TMF) to electronic trial master file (eTMF) management in clinical studies, and the changing regulatory landscape.

“If an organization that is engaged in a clinical trial desires to uphold compliance, they must effectively manage and maintain all trial-related content, documents and data to support the claims of the trial and also prove that the trial was conducted in a complaint manner,” said Patricia Santos-Serrao, RAC, director of clinical and regulatory solutions of MasterControl Inc. “The collection of this information makes up the trial master file, which can be streamlined if created electronically in the form of an electronic trial master file or eTMF. The eTMF needs to be both accurate and organized in a way that is acceptable for evaluation by regulatory inspectors as well as sharing internally and externally. This white paper provides insights for organizations to leverage an eTMF to better manage clinical trials and, ultimately, bring products to market faster.”

In the white paper, MasterControl introduces and defines the TMF, proposes TMF document management strategies, and discusses the TMF Reference Model, which is the industry standard of organization and best practices related to TMF management that is recognized by all clinical trial stakeholders, with a view to be adaptable and adopted by any organization.

It also provides a TMF Reference Model (Version 3.0) Artifacts Cheat Sheet, which is valuable to anyone seeking a best-practice approach. The TMF Reference Model is managed under the auspices of the Drug Information Association (DIA) Document and Records Management Community.

The eTMF Management Essentials white paper is available for download directly from MasterControl at http://www.mastercontrol.com/laboratories/eTMF-Software-Systems.html or upon request at the MasterControl booth #1632 at the DIA Annual Meeting June 19-21, 2017 at McCormick Place in Chicago.

About MasterControl

MasterControl Inc. produces enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions securely manage a company's critical information throughout the entire product lifecycle while reducing overall costs and increasing internal efficiencies.  More than 1,000 companies worldwide ranging from five employees to tens of thousands use MasterControl’s suite of scalable cloud solutions for document management, quality management, electronic batch record management, supplier management, and clinical and regulatory information management. MasterControl solutions are known for being easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.

 

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