This organization, a major life sciences regulatory authority in the United States, sought to transform its submission review operations in order to respond more quickly to emerging scientific, technological, and economic trends.
The organization wanted to increase employee productivity and accountability, while also providing them with more accurate and timely data for more informed business decisions. The organization’s processes were mostly paper-based and tended to be localized within branches, divisions and specific product-type areas. Data for review was stored in text documents, making uncovering specific information difficult. Document sharing was done largely via a legacy application tool and shared network drives. In addition to impacting performance, the environment also made training new reviewers difficult.
Using Appian, the organization created a digital review application for handling submissions of 510K applications for premarket authorization requests of medical devices. The application integrates with existing systems to unify technology, bringing functionality of legacy systems up to modern day expectations while leveraging existing investments. The result is a consistent, repeatable, and standardized process that uses automation to increase data quality.