The way we create, review, localize, store and manage documents in the pharmaceutical industry today bears a striking resemblance to the story of Frankenstein’s monster (at least in the original film version). Several tools, systems and processes are cobbled together to manage the high volume of documentation needed to support drug development and commercialization, without much planning, testing or feedback.
How did we get here?
Like many sectors, the pharmaceutical industry is known for functional siloes, which make it difficult to communicate and collaborate across the enterprise. The challenges are magnified when multiple systems are involved, and further compounded when information needs to be shared, or when larger documents, such as submissions, need to be created collaboratively across business functions.
It starts with scattered information and broken processes.
When you’re creating a document that cuts across functional areas, such as a regulatory submission, medical writers, subject matter experts and/or authors must spend time identifying and retrieving content, by searching across multiple systems (drives, folders, other storage systems) and emailing various contributors to find the most up-to-date content. When more than one author is involved, people must either work independently on their sections, or documents must be checked in and out, making collaboration more complex.
The evolution of Frankensystems
Identifying content, creating documents, reviewing and localizing documents is challenging enough without complicating matters further by using multiple systems. But this approach started because an integrated solution wasn’t there to support the end-to-end process, so companies addressed each sub-process as technology became available. Today, “Frankensystems” persist and multiply in the absence of an integrated strategy that brings together business and IT goals, and manages information, documents and the supporting processes.
Can you banish the monster—or at least teach it to dance?
Yes! The first step is to examine your information and document management approach and pain points, with an eye towards developing enterprise solutions. When you look at your information requirements from a higher level, and address specific business unit and IT needs, a comprehensive approach to information and document management will save time and money, improve compliance and free up key talent to work on higher value activities.
When considering your information management strategy, it is important to remember that software and other technology tools are merely enablers of the overall solution. No tool can fix business processes that don’t work well or engage people to use them. Assessing and improving your business processes and practices and developing a change management and communication plan will also help you “tame the monster.” In the next post we will discuss technology options that provide an end-to-end solution for creating, reviewing, approving, localizing, storing and managing regulated and controlled information.
How can you can address your own “Frankensystem” nightmare, engage leadership, manage change, and start on the path to a better way? Contact TransAccel Group by reaching out to Mark Lane or Bruce Lotier.
