We’re all well aware of the rapidly changing and increasingly more complex regulatory environment for life sciences companies, but what does that actually mean for those tasked with complying with the regulations and making sure content is managed intuitively, and in keeping with the commercial needs of the organization?
By Jason Halpern, Product Manager, CSC Life Sciences
For the vice president of regulatory affairs, it’s about having a content management platform that will achieve your objectives: It has to reduce the total cost of ownership (TCO) through a blend of technology and best practice business rules that enable your organization to adopt and flex with the system. Ultimately, it’s about seamlessly managing the constant demands placed on your department – planning, tracking, submission management; plus compliance, product, corporate mandate, and partner changes. How do you align what’s in the market to your expectations? What do you look for?
All the while, you are staring down the barrel of new, more complex regulations that will impact your content management.
In this environment, you need your personnel to be able to view, contribute and approve documents across all kinds of boundaries – whether they are in different offices, time zones, or even in different corporations, which has become more prevalent as pharma companies start to collaborate more to develop new, innovative products. You want and need a solution that facilitates collaboration in a way that’s efficient and isn’t impeded by working across different entities or systems.
There are also time pressures. As vice president of regulatory affairs, you don’t have months to manage configuration or to train your user base. You need a solution to be available as quickly as possible and usable almost immediately. You need the system to be up and running so your personnel can stay productive. So your priority is an intuitive, user-friendly interface.
For the head of IT for regulatory operations the challenges might be quite different. For those leaders, the pressure points center on timeframes of roll out, cost of rolling out a solution, scalability and stability.
Often the desires of IT regulatory operations and regulatory affairs conflict, so it’s important to have a platform that can satisfy both.
With next generation FirstDoc, user experience has been a priority in development. Having a user interface that is intuitive and easy to use addresses many of those issues of user productivity and quick configuration. It’s about meeting systems expectations and giving users – who are now accustomed to Google and other such platforms and social media – an interface that is familiar, so they can focus on their jobs rather than the system.
From an IT point of view, the fact that CSC can host FirstDoc simplifies the process of rolling out the solution, managing it or implementing upgrades. If you, as a regulatory operations IT or regulatory affairs professional have seen FirstDoc in the past – it’s time to take a second look. The FirstDoc Next Gen User Experience is just that, and it’s changing everything.
Come and see us at booth #100 at the DIA Regulatory Submissions, Information, and Document Management Forum from February 8 to 10 to learn more about FirstDoc Next Generation User Interface.