Precision BioSciences deploys PIMS in support of its manufacturing operations by having one source of data truth and streamlined batch review and verification.
IDBS will be running our annual experience event, i3, again in June this year!
Discover the practices to achieve the level of process knowledge required for successful technology transfer and how they are preparing for the shift from static tech transfer to dynamic, persistent and compliant knowledge sharing.
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.
Therapies are more complex, tailored and varied than ever and the associated amount of data is growing – which requires a new level of attention to detail.