Three Ways to Ensure Your Compliance Practices Are Mobile Friendly


Mobile technology is transforming nearly every facet of today’s pharmaceutical businesses—
across research, sales, marketing, manufacturing, distribution and the full spectrum of customer touch points. The impact on productivity is undeniable, and the addition of mobile access also fuels cost savings, innovation and a better overall customer experience.

The downside, however, is that significant new business vulnerabilities have emerged as a result of the mobile movement. That’s why pharmaceutical companies must establish protective policies to ensure their mobile initiatives don’t put regulatory compliance and quality management at risk. Here are three precautions you can take to better ensure your mobile-enabled practices are enterprise-grade:

  1. Use the Right Tools

Mobile computing is a force that is here to stay in the pharmaceutical sector, which is why it’s important to be smart about its use. This is true particularly with regard to mobile practices surrounding the management of business-critical content assets.  To address the new demands presented by the mobile era, leading enterprise information management (EIM) systems have introduced mobile apps for their solutions for use on most smart devices (iOS, Android, and Windows). These apps allow authorized employees to effectively manage, process and share information from wherever they are. Unlike most enterprise file sync and share solutions, these apps can grant employees easy mobile access to content while ensuring that EU or FDA regulatory requirements are being met.

  1. Ensure Mobile Activities are Tracked and Logged in Audit Trails

When it comes to regulatory compliance, an audit trail is an essential proof point. However, with widespread mobile access to information assets, and employees participating in reviews, approvals and other workflows from their mobile devices, it has become increasing difficult for pharmaceutical businesses to ensure their audit trails are complete and comprehensive. Even version control is becoming more and more challenging as different copies are managed in multiple online and on-presmises repositories. Fortunately, with the modern EIM mobile apps, activities of remote workers are now fully trackable and available for review as part of the overall audit log trail. In fact, many modern EIM platforms are set up to organize and manage all compliance-related documents, along with associated processes, incorporating everything from complete version history and automatic permissions to workflow steps—regardless of whether the activity was performed on site or on the go. Some advanced EIM mobile apps also support strong authentication mechanisms such as geo-fencing and multi-factor authentication.

  1. eSignatures for Improved Workflow Efficiency

Electronic and digital signatures, or eSignatures, have become indispensable in all facets of business today, and they are a key component of FDA 21 CFR Part 11. Because eSignatures can now be executed on mobile devices, they can serve as a linchpin for your mobile compliance initiatives. With mobile eSignatures, a business can eliminate bottlenecks, save time, add efficiency and support employees when their principal communication vehicle isn’t an on-premises-based workstation or application.

Consider this: if your research team updates a standard operating procedure (SOP), an alert notification can be automatically sent to all employees impacted. In this way, remote users will be able to not only view the updated SOP from their mobile devices, but also acknowledge—with an electronic signature verification—that they have read, reviewed and understood the new policy. Best of all, today’s EIM systems can implement and automate these information workflow processes across the mobile landscape, making for improved efficiencies, streamlined communication and a better and more complete audit trail.

With the skyrocketing rise of mobile adoption, it’s evident that the associated vulnerabilities for pharmaceutical businesses are vast—and many risks still remain undiscovered. Although the rewards of mobile computing far outweigh the risks, the time has clearly come to ensure that critical compliance policies are supported in the field to the same degree they are supported in the office.