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It’s a RAP: Looking Back on the RAPS Regulatory Convergence

By Litera Microsystems on September 21, 2017
Litera Microsystems

Several of the folks at Microsystems have recently returned from Convergence, the annual meeting of the Regulatory Affairs Professionals Society (RAPS). RAPS is the largest organization for individuals who work in health-care regulation, including medical devices and pharmaceuticals. RAPS was a great chance for us to rub shoulders in that industry and to meet some terrific people.

We were excited to see where these fields are going and how we can help them get there. Here are a few of our key takeaways from the 2017 Convergence.

Businesses that work in health-care regulation need automated quality control reviews

According to one of the short surveys we conducted at RAPS, the most sought-after feature businesses are looking for in their document software is an automated QC review. Over 80% of the users we surveyed believe that they could speed up their submissions if they used smart technology to complete these QC reviews. Since submission timelines were the most urgent business issue for fully one-third of the people we surveyed, the ability to speed up submissions would relieve significant stress and offer a tremendous competitive advantage. This is a huge area for potential innovation and process improvement.

Precisely formatted documents are critical—and technology can streamline their creation.

Electronic Common Technical Documents (eCTDs) are the standard format for many applications and reports to the Food and Drug Administration regarding pharmaceuticals and biologics. Each eCTD must be precisely formatted to be considered. Currently, nearly half of the people we spoke with are still formatting their documents manually, which is a time-consuming and repetitive process. As technology aficionados who work daily with artificial intelligence and process automation, we were excited to hear how this area is ready for a technological revolution.

Sophisticated wraparound document services are lagging in health-care regulation.

Within the life sciences and health-care industries, clear and consistent communication with regulators and consumers can literally be a matter of life and death. Everyone in these fields has to deal with documents—such as FDA applications, technical reports, or testing results—which means they can all benefit from innovative and effective solutions to their document problems. Life sciences professionals specialize in science, not in documents. Yet we spoke with so many people who have had to waste valuable time fighting with their word-processing software to get the nitpicky details right. We also met a number of people who are working with medical devices and in other specialized fields where document services are suffering from a deficit of technological innovation and process reinvention. 

We’re fired up about how we could help some of the RAPS attendees we met produce clear, clean, consistent documents that are 100% correct and that meet all their regulatory formatting and content requirements—and do so quickly and easily. We were excited to let these folks in on the secret to making their documents beautiful!

Topics: Life Sciences, Events

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