Today's applications are saying to content: "Don't just sit there, do something!"

MedTrials is a midsize contract research organization that has been managing clinical trials for more than 20 years. Its legacy document management vendor was no longer developing additional capabilities in its product to keep up with changing demands, so MedTrials began exploring other options. "At a certain point we needed third parties to be able to access our documents electronically," says Brian Morgan, COO of MedTrials, "and our system could not do that." MedTrials investigated a range of products from industry-specific solutions to generic ones, and decided that M-Files Document Management System (DMS) met its requirements.

The top issues that MedTrials wanted to address were document versioning, ability to define workflows, tight security and effective administration so that teams would have access to the appropriate documents. "Previously we could store documents but did not have workflow capability or digital signatures," Morgan says. Partly because of the highly regulated nature of the industry, companies have been slow to evolve away from paper. "Many of our documents require five or six signatures," he adds, "and it was hard to get people to give up the wet ink signature. But gradually our employees and partners realized that we would achieve savings both in time and cost, without sacrificing security."

Shift to transparency

A typical process might begin with the development of a new standard operating procedure (SOP) governing a process. "As a draft SOP is developed, it is automatically put into the workflow for review and approval, and if it is not reviewed or signed within the timeframe, an alert is sent," Morgan explains. The audit trail provided by M-Files DMS allows managers to review comments of other reviewers, and the senior manager of quality assurance at MedTrials can view a summary of all the documents that are out for signature.

Part of the cultural shift when document management is automated for compliance is that the system provides complete transparency. "In knowledge work, getting a handle on who is doing what can be difficult," Morgan says. "With M-Files DMS, both compliance and productivity are exposed." A reporting module in the software is being used extensively for analysis of compliance procedures to make sure they are complete and accurate.

MedTrials worked with M-Files to develop the initial workflows. "We used a ‘train the trainer' approach so that our staff could take over management of the system," Morgan says. "Now changes can be made to the workflows and metadata in house whenever we need to modify the system."

The storage model used by M-Files differs from that of other ECM systems. "Rather than using a folder system in which a copy of the document is stored in a particular location, M-Files shifts the equation and drives the entire system based on ‘what' information is rather than ‘where' it's stored. We do that with a unique metadata-driven approach," says Greg Milliken, president of M-Files.

Easy access

Documents can be saved by dragging and dropping them into the M-Files vault. The first time a document is saved, the user identifies a few key pieces of metadata and enters a brief description. Documents can be accessed easily in a number of ways. For example, users can conduct a keyword search based on the document's metadata or content, or select a category such as "proposal" and then indicate the customer, date range or another identifier.

Rather than accessing documents via a particular folder, M-Files dynamically organizes and displays documents based on the parameters of the specific search request. That approach enables users to find the right information instantly while making the same document available to all users without creating different file versions and copies. Users can easily bring up a particular document, or all of the documents associated with a client, for example.

M-Files has targeted the compliance space as a key market, but its software can also provide enterprise content management for other uses. "There are products that are specially designed for monitoring quality and compliance in the FDA or ISO environment," Milliken explains. "However, these very specialized compliance products typically are not suitable for managing documents for more general processes such as general review and approvals, or invoicing and contract management. We can address both use cases."

M-Files DMS is designed to balance ease of use with features needed for enterprise-level content management. "At one end of the spectrum are products that allow document sharing through simple cloud-based folder systems, and at the other are high-end, feature-rich but expensive products that have a steep learning curve," Milliken says. "We target the middle ground with a product that is easy to use but still has a robust content management capability."