Many complex steps are involved in the pharmaceutical production chain. Their execution and documentation need to be done with extreme precision, during both the very first run and the many later repetitions. Doing this manually not only ties up valuable resources and skilled labor, it also consumes more time and increases the likelihood of errors. A comprehensive digitization of production systems can pave the way for increased process reliability, accuracy and efficiency. The potential of this is best demonstrated by the use of Electronic Batch Recording (EBR) in the execution, documentation and approval of batches.
If pharmaceutical manufacturing processes are executed manually and documented on paper, this can increase not only risks, but also delays. If quality assurance experts are called over to monitor the relevant production steps, this can tie up urgently needed resources—especially in the case of product variants. Furthermore, paper-based documentation often results in errors.