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SimplerQMS and M-Files speed go-to-market for life sciences startups


M-Files, an information management company, has announced that SimplerQMS, a 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 startups.

New life-saving medical treatments can take 3?12 years to develop, partly because of extensive regulatory requirements.

SimplerQMS, a ready-to-use eQMS powered by M-Files and Microsoft Azure, combines 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.

“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,” said Jacob Sjørslev, CEO at SimplerQMS.  "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,” said 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, offers a way for companies to improve efficiency while ensuring compliance with regulations, according to Greg Milliken, senior vice president of marketing at M-Files.

The offering is a great example of how subject matter experts and consultancy firms can leverage M-Files to turn their expertise into a cloud-based solution that differentiates, sells, and scales at the same time, he added.

The M-Files intelligent information management platform provides a AI-powered 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 at www.SimplerQMS.com.

To learn more about M-Files, visit www.m-files.com.


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