The job of a regulatory professional has become increasingly global. According to RAPS' most recent Scope of Practice and Compensation Report, 72% of regulatory professionals in North America and Europe, have multiregional or worldwide scopes of work.
There is a lot to keep track of in a large, global organization. Managing an organization's complex regulatory information and documentation across a global network of affiliates can be a significant challenge.
According to a 2013 survey of global organizations by Gens and Associates, 40% of local regulatory professionals' time is devoted to managing regulatory information, and 25% of that time is spent on duplicative activities like re-entering basic information. To minimize or eliminate such wasted effort, life science companies have to proactively design global regulatory content management systems to meet their specific objectives.
There are some important points to keep in mind when creating a regulatory content management system, says Lalana Dararutana, a senior consultant with Veeva Systems, a cloud-based software company working with clients in the life sciences. Dararutana recently discussed some of the key considerations during the RAPS webcast, Designing Global Systems with the Affiliate in Mind, sponsored by Veeva. The webcast recording is now available free online.
One of the keys to any system is accessibility, says Dararutana. "Having a central, authoritative source for content and data is key. This 'single source of truth' needs to be accessible across the network of resources." If a mission-critical piece of information is not available to the right people at the right time, it is going to result in wasted time and effort.
The system also must be usable by all stakeholders. "It has to be easy for that global network to search and retrieve information or work on the authoritative source of content, regardless of their location," says Dararutana. With teams and team members spread out, you must ensure that the system is as usable to your people in Beijing as it is to your people in Boston.
It also must be flexible enough to satisfy all concerned. "A system should have the flexibility to meet both the needs of the primary headquarters and the local affiliates or partners around the world," says Dararutana. A system that requires staff in remote locations to create workarounds is an inefficient one.
Building a global, well organized system for regulatory information is far from simple or easy. The complexity of the content itself makes it a challenge. And the more stakeholders involved, the more you will have to coordinate. In addition, creating such a system may mean overcoming internal resistance to change and surely will require significant investment. But implementing the right system for your organization will result in improved efficiency across geographic and departmental lines, and enable greater standardization and dissemination of best practices. In the end, it is an investment in your organization's productivity.