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Are Your Compliance Practices Cloud and Mobile Friendly?

Tue, 07/01/2014 - 3:23pm
Mika Javanainen, Senior Director of Product Management, M-Files Corporation

The “bring your own device” (BYOD)-enabled workforce is altering the landscape of compliance-related content management. Medical device companies should take this trend seriously because if you implement your BYOD strategy well, it can have positive impact on productivity and collaboration within your organization. Conversely, if you don’t put controls and guidelines in place for how employees access and share documents from their mobile devices, many of them will likely start using popular online-sharing tools, such as Dropbox, for managing corporate data.

The BYOD trend is the key driver in the rise of popular cloud file sharing and sync solutions, since enabling employee access to corporate data via their personal devices is much easier if the content can be accessed via the cloud.

Medical device companies and other highly-regulated businesses typically face three challenges when implementing their cloud and mobile strategies:

  1. Certain documents may be too sensitive to be replicated in the cloud
  2. The system to manage the data in the cloud must be optimized for mobile use
  3. The data managed and processed in the cloud must be in compliance with regulatory requirements

Some enterprise content management (ECM) solutions offer a way to replicate only select documents to the cloud based on their attributes. These enables a medical device company to, for example, allow their employees to access product data sheets with their iPads, whereas classified R&D documents are only accessible from corporate devices and systems.

One of the main reasons why Dropbox and other online-sharing tools have become so popular is because they are designed for mobile use. The main issue of allowing employees to use these tools to access and manage corporate data is that the audit trail and chain of command is easily lost when the document leaves the corporate data repository.

The good news is that leading ECM solution providers have invested significantly in their mobile apps and provide an easy-to-use experience for users to access corporate data with tablets and smartphones. In addition, these solutions ensure that the data never leaves the repository while maintaining a rigid and comprehensive audit trail. The most advanced systems also support electronic signatures that enable employees to sign off documents and tasks from their mobile devices. Beyond convenience, this capability actually improves workflow efficiency while fulfilling the most stringent regulatory compliance requirements such as those associated with FDA 21 CFR Part 11.

ECM mobile apps also provide entirely new ways to further enhance information management processes. Built-in cameras enable employees to capture photos as evidence of a completed task such as replacing a bedside medical instrument. And mobile devices with GPS capabilities allow users to take advantage of location-based search functions to capture further proof of compliance and improve oversight.

Medical device companies can experience substantial benefits by enabling their staff to use mobile devices for compliance-related content and process management-related activities. From providing mobile access to information employees are authorized to access, edit and share – to streamlining workflows and automating compliance procedures, regulated companies can make their staff more productive while maintaining control over confidential information and ensuring ongoing compliance.

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