In Life Sciences, Can We Achieve Compliance Without the Complexity?

26 October 2011 | Matt Walz, Co-Founder and Chief Technology Officer, NextDocs

Compliance can be complex, especially when it comes to the specifics of an industry’s government regulations. One such example is Title 21 CFR Part 11 of the Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures in the United States which can be very complex. But the complexity of the regulations does not mean companies have to live with a difficult software system. By leveraging a standard, scalable, and integrated platform that allows for collaboration and automated processes, companies can address their compliance needs more easily than previously thought.

NextDocs client, Sanofi, a multinational pharmaceutical company, explained in a recent case study how they have reaped the benefits of choosing an integrated approach to compliance.
The company looked to replace manual, paper-based clinical trial processes with a streamlined compliant document management solution operating in a global, web-based collaborative framework. To do this, sanofi implemented the NextDocs Clinical Trial Portal in their Microsoft SharePoint Server environment.
The result was increased productivity, reduced costs and a competitive advantage. In fact, sanofi expects that, over the next few years, this solution will save an estimated 10,000 working days and $9 million USD in time which would have been wasted managing documents. Even more important than increased productivity and cost savings is the faster time-to-market for a new drug.
When we spoke with sanofi, they described the benefits of the system within four main buckets:
Usability – Users quickly adapted to the new environment
Scalability - The NextDocs solution can expand with sanofi as they roll-out the program across their 3,000 users, 10,000 hospital sites, and 30,000 to 40,000 doctors.
Efficiency - By replacing outdated paper-based processes with an electronic data exchange sanofi’s teams work together more quickly and efficiently.
Management - Real time trial documentation and aggregation gives executives an accurate, up-to-the-minute insight into global operations.
Maintaining compliance throughout your organization doesn’t need to be a burdensome or complex process. As sanofi and other have realized, by selecting a platform and a partner that will seamlessly integrate all aspects of the process, companies are better able to streamline compliance procedures.
In the past, it was difficult for compliance solutions to adequately meet the diverse needs of their users. The systems wouldn’t scale well because they were proprietary in nature. A user had to learn and stay up to date with several systems to accomplish a single workload. Plus, the antiquated platforms on which these systems were built were not user friendly to begin with. And, not all departments within a company would use the same versions of the system, or even the same systems. This resulted in multiple sets of training, multiple release schedules, multiple sets of license and maintenance costs, and multiple vendors to manage. Simply unsustainable – life sciences companies began looking at how they could leverage one single collaboration platform facilitates integration and, importantly for the user, provides a familiar set of tools with which do to their job.
Over the years, we also saw a number of point solutions put in place to solve individual aspects of an overall compliance workload. Consider the workload of Quality Management in manufacturing environments. It’s common for a company to have one system to author, review and approve Standard Operating Procedures (SOPs); another system to track employee training on those SOPs; and a third system to track deviations against those SOPs. Each of these solutions takes time to implement effectively. They also can be costly in terms of support and, most importantly, are often unable to integrate with each other.
NextDocs’ philosophy has helped change that. As Microsoft’s Life Sciences Partner of the Year for the past two years, we strive to provide life sciences customers with a better user experience. To do so, we’ve built products on an industry standard technology, seamlessly integrating once siloed point solutions under a single umbrella to eliminate complexity.
Matt Walz
Co-Founder and Chief Technology Officer, NextDocs