The Demands of Regulatory Information Management in a Global Environment

Posted on April 5, 2012 under Advice by

Today’s global companies produce immense amounts of data – so much so that their disparate systems often struggle to adequately store and organize all of it. This dilemma becomes more complex and challenging for organizations that must adhere to industry regulations and standards, or if they operate in audit-intensive and quality-driven environments.

Most companies know they need a better approach to regulatory information management – what they often don’t know is where to start and how to weave this vital capability across the enterprise’s diverse business applications.

Data is generated by the day-to-day activities that take place in each department. In most cases, data gathering is conducted locally, with responsible departments drawing on the minimal amount of information needed to adhere to regulatory requirements or to track commitments. However, what is often missing is the ability to aggregate information across the enterprise so that it can be used to conduct more predictive work, such as project planning across the portfolio, resource planning, and pre- and post-sales activities.

Accurate and up-to-date information is needed to establish quality management principles, describe specific processes and procedures, and maintain records that demonstrate such processes and procedures were followed. In so doing, companies can manage their activities more holistically and better equip themselves to recognize and act upon information that can impact quality and operations.

With a formal enterprise content management (ECM) solution in place, companies can simplify compliance procedures, streamline processes, automate information exchange and reduce administrative overhead. As a result, teams can work together in a more effective and efficient manner by keeping personnel connected, informed and on task – providing access to the right information to everyone at any time, from anywhere.

In the M-Files white paper, Leveraging Information Management to Improve Quality Systems and Processes, we raise the point that regulatory information management involves far more than just tracking submissions, and that the processes and technologies employed to enable successful regulatory content management can also help companies consolidate their disparate systems and produce meaningful information that leads to better decision-making.

About M-Files

M-Files dynamic content management solutions are revolutionizing the ECM market by transforming how businesses manage, secure and share information with a unique metadata-powered approach that organizes and processes content based on what it is, rather than where it resides. Thousands of businesses in over 100 countries use M-Files on-premise, in the cloud or in hybrid environments to improve productivity and quality, and to ensure compliance with industry regulations and standards, including companies such as SAS, Elekta and EADS.

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