Whether you're applying for premarket approval in the U.S., a CE mark in Europe, or a Shonin in Japan, the ...
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This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.
Your organization can improve the metrics that matter most to your manufacturing operations by using digital production records found in Manufacturing Excellence. Learn more...
Being successful in manufacturing today requires more than selecting the right manufacturing software. It entails digitization all the way to the shop floor. Read more...
U.S. FDA now puts an emphasis on adapting new technologies to make the food supply chain safer. Fortunately, preparing for new regulations and complying with the FSMA can both be done by digitizing.
In a regulated environment, the document control process can either be an obstacle course replete with pitfalls, or it can be a smooth ride to a successful product launch.
Device history records (DHRs) are the most important artifacts generated in the course of medical device manufacturing, yet many manufacturers still rely on manual, paper-based DHR systems.
According to Garner Research, by 2019, over 75% of Life Science R&D IT organizations will adopt cloud-first application deployment strategies.