By John Lawrie, Vice President, Vault RIM, Veeva Systems
Across the life sciences industry, companies are increasingly focused on how they can improve the speed and efficiency of their operations. This is especially true now with greater attention being paid to drug prices. From the clinical through the commercial phases, companies are seeking unique ways to reduce costs to maintain their margins; regulatory operations is no exception.
One new approach being explored is “continuous publishing,” which reduces steps in a traditionally lengthy process. Continuous publishing replaces serial publishing with a parallel process where regulatory teams identify issues in real time rather than waiting until the end. This allows regulatory teams to resolve validation errors faster and eliminate cumbersome manual hand-offs to significantly reduce time from planning to submission.
Continuous publishing is similar to continuous manufacturing, another promising model that’s widespread in other industries and is starting to replace traditional batch manufacturing in the life sciences. Vertex, Johnson & Johnson, and Eli Lilly are a few of the earliest adopters of continuous manufacturing, which is essentially an end-to-end assembly line where raw ingredients are seamlessly processed in a single production line that ends with the finished product. As is the case with continuous publishing, the aim is to improve efficiency, quality, and speed.