Paper-based processes are inefficient and error-prone
Sponsors’ demands are growing and complex, which have many CDMOs/CMOs pushing to become leaner and digital. To be agile enough to meet sponsor requirements of patient delivery deadlines and frequent schedule changes, an Electronic Batch Record solution should be a minimum prerequisite. Paper-based manufacturing systems are too slow and cumbersome in the cell therapy world. They lack the ease for tracking of data and continuous improvement.
For instance, given the volume of different manufacturing processes in the cell, gene and stem cell space, contract manufacturers must continuously manage customers’ work instructions and standard operating procedures (SOPs) which change regularly. Operator training, manufacturing recipes and product specifications also vary and need to be updated frequently. Accurately and safely managing all of these changing documents via paper-based records is incredibly challenging and inefficient, with significant risk for harmful errors, delays and a lack of transparency.
In conclusion, CDMOs/CMOs must embrace digitization. A cloud-hosted digital electronic batch records solution coupled with a flexible scheduling solution and integration to other supply chain and IT systems is the “need of the hour” today. With an EBR, cell therapy sponsors can monitor the CDMO/CMO process right from their desk. The most important compliance parameters of chain of identity, chain of custody, chain of condition and limited time horizon for critically ill patients can be monitored right at one’s fingertips. Any events, delays or changes can be addressed immediately.
With some upfront initial effort, CDMOs/CMOs will save a lot of effort downstream when data is integrated across the enterprise and quality and production teams are relieved of an enormous documentation burden. Companies who have adopted EBR have reported an 83% decrease in data input errors and more than 87% decrease in review time after production completes by embracing the review by exception paradigm.