SimplerQMS and M-Files Accelerate Go-To-Market for Life Sciences Startups
Industry experts develop ready-to-use, validated quality management system to make leading-edge, cloud-based compliance solutions accessible to any life sciences business
DALLAS, June 6, 2019 /PRNewswire-PRWeb/ -- M-Files Corporation, the intelligent information management company, today announced that SimplerQMS, a highly-experienced software company focused on quality management processes in life sciences, has selected M-Files as the platform for its cloud-based quality management system (eQMS) targeted at life sciences start-ups.
New life-saving medical treatments take three to 12 years to develop, partly because of extensive regulatory requirements. SimplerQMS, a ready-to-use eQMS powered by M-Files and Microsoft Azure, combines this state-of-the-art scalable cloud technology with its 30-plus years of experience in medical devices and life sciences. It enables customers to shorten time-to-market while minimizing compliance risk; prepare for ISO, FDA and EudraLex audits; ensure certification for ISO 13485 and other standards; and support effective collaboration with a prize-winning, cloud-based solution.
"I have worked for many years as a CIO in the life sciences industry, and I've found that companies are often on their own when it comes to rolling out IT systems. This is particularly challenging for those who need approval from regulatory authorities," said Jacob Sjørslev, CEO at SimplerQMS. "I saw a clear need for a simpler, more cost-efficient way for life sciences startups to comply with regulations."
"Today, most startups in highly regulated industries are still storing their documents in file folders, which in regulatory terms are 'uncontrolled' and therefore can't be accepted as valid documentation by the authorities," continued Sjørslev. "As a result, they need to maintain a paper archive, which requires manually printing, distributing and signing documents. This process is time-consuming and inefficient, and it increases regulatory risk."
Fluisense, a SimplerQMS customer that developed a wearable automated blood sampling system, spent thousands of hours keeping paper-based documentation up to date and compliant with regulations before adopting SimplerQMS and M-Files.
"We had been looking for a vendor that has deep industry knowledge, is ISO 13485 certified and is offering solutions based on proven technology. With SimplerQMS and M-Files, we found a solution that we expect will save us significant time by moving more than 60,000 documents into automated workflows and digital signatures," says Malene Schrøder, CEO of Fluisense. "We also look forward to being able to quickly find the right documents, follow up on documents that are in process and ensure that old versions are archived. When SimplerQMS is fully implemented, we expect to convert the work of one to two full-time employees from manual processes to more value-creating activities."
"M-Files technology, coupled with SimplerQMS' deep insights into life sciences quality management, offer a compelling value for customers looking for ways to improve efficiency while ensuring compliance with regulations," said Greg Milliken, senior vice president of marketing at M-Files. "SimplerQMS is a great example of how subject matter experts and consultancy firms can leverage M-Files to turn their expertise into a tangible, cloud-based solution that differentiates, sells and scales at the same time."
The M-Files intelligent information management platform provides a rich AI-powered set of capabilities for document and process management, workflows, collaboration, advanced search, access control and much more. M-Files provides connectors to almost any content repository or business application, along with instant cloud readiness. In addition, the M-Files team provides dedicated services to consultancy firms and subject matter experts to turn their knowledge into cloud-based software solutions. Support from M-Files spans from training to development to full-fledged partner programs.
More information on SimplerQMS can be found here: https://www.SimplerQMS.com
To learn more about M-Files, visit: https://www.m-files.com
About M-Files Corporation
M-Files provides a next-generation intelligent information management platform that improves business performance by helping people find and use information more effectively. Unlike traditional enterprise content management (ECM) systems or content services platforms, M-Files unifies systems, data and content across the organization without disturbing existing systems and processes or requiring data migration. Using artificial intelligence (AI) technologies in its unique Intelligent Metadata Layer, M-Files breaks down silos by delivering an in-context experience for accessing and leveraging information that resides in any system and repository, including network folders, SharePoint, file sharing services, ECM systems, CRM, ERP and other business systems and repositories. Thousands of organizations in more than 100 countries use M-Files for managing their business information and processes, including NBC Universal, OMV, Rovio, SAS Institute and thyssenkrupp. For more information, visit http://www.m-files.com.
M-Files is a registered trademark of M-Files Corporation. All other registered trademarks belong to their respective owners.
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SOURCE M-Files
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