Biopharmaceutical companies generate a vast amount of high-value process data that are typically stored in paper records, data silos, and in the minds of key personnel. This represents valuable corporate knowledge that is often lost or ineffectively used. The manual transcription involved in recording process data necessitates high QA overheads and makes obtaining a holistic view of the processes problematic. It is both time-consuming and costly to support decision-making, root cause analysis, and continuous improvement.…
Author Archives: Pietro Forgione
Bioprocess Data Management
IDBS provides a flexible data management solution that meets the diverse demands of biologic drug development based on our extensive experience working with global biopharmaceutical and contract manufacturing organizations. the IDBS Bioprocess data Management solution enables streamlined execution of process workflows, improved data access, sharing and reporting, and the process insight needed to successfully reduce the time and cost required to deliver new biologics to market. Managing Diverse Data Biopharmaceutical companies generate a…
Data Management in the Supply Chain
Adopting an effective strategy for data and knowledge management throughout the drug development and clinical manufacturing lifecycle is key to maintaining a competitive edge. Significant challenges face each organization seeking to improve efficiency in this area, and they can mostly be attributed to the complex nature of pharmaceutical drug development. Managing both data and knowledge is complicated by the different groups, sites, and partner organizations involved with developing and manufacturing a new drug product. To further compound the problem, a…