Many companies worry they may not be approaching software validation correctly since regulatory agency guidelines lack clear, specific methods. But our Validation Excellence Tool (VxT) uses a risk-based approach, making validation easy by guiding you through clear steps.
The fully connected Manufacturing Excellence solution reduces production errors, improves cycle times, enhances line performance, accelerates product release, and integrates manufacturing and quality.
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.
While already overseeing the world’s second-largest pharmaceutical market, China’s State Administration for Market Supervision is working to bring international drugs into the Chinese market faster.
The manufacturing sector is firing on all cylinders, but that doesn’t mean executives aren’t still seeking ways to reduce costs and achieve greater ROI.
Ever since 1991, GAMP has worked to help the life sciences validate their computerized systems as fit for intended use and compliant with regulatory requirements. Learn more, read the white paper.
Industry 4.0 involves the digitization and interconnectivity of all functional entities. Key players in this trend include big data, advanced analytics, automation and cloud computing.
