Process Performance Qualification (PPQ): Early adoption of digital process systems puts you in control
Software brings value to PPQ activities by bridging the gap between PD and manufacturing.
Software brings value to PPQ activities by bridging the gap between PD and manufacturing.
Work smarter, not harder, with digital workflows that capture process and analytical data in full context right from the start.
Improve your throughput with consistent data capture, powerful analytics and rapid reporting capabilities.
Why don’t scientists use data to its full potential? In this article, we will discuss the blockers to data use and re-use and explain why the R&D industry urgently needs to remove them.
In 2012, Harvard Business Review put data science on the map, calling it the “sexiest job of the 21st century.” But what is it exactly and how does it align with analytics, informatics, process intelligence and all the other terms you’re seeing in the business press these days?
Bioinformatics has become a powerful component in the field of science, and its induction to the global industry has marked a turning point in many areas, such as healthcare, gene technology and medicine.
Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures
Life Science manufacturing data management has become increasingly difficult with advancements in complex biopharma and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging behind those in other pharma operations, there’s a demand for accelerated tech transfer, FDA filings and commercialization. There are new business demands for information to be processed faster.
In the life science industry, like many sectors, Excel is a proverbial hammer. However, not all problems are nails. Launched by Microsoft in the 80s, Excel has become ubiquitous as a tool for every department and workflow imaginable, ad hoc analyses, back-of-the-envelope calculations and more.
Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. The key determinant to achieving success is the exchange of accurate, compliant data in relevant time.