Boosting efficiency and productivity with Electronic Batch Recording (EBR)

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. 

Improving efficiency and preventing errors through digital guidance

With an MES (Manufacturing Execution System) such as PAS-X from Körber, the execution, documentation and approval of each work step is done electronically. “With Electronic Batch Recording (EBR), the production process is managed digitally,” explains Kübra Bakirci, Associate Sales & Business Consultant Software in the Körber Business Area Pharma. Operators are methodically guided by a mobile device through particular production steps, which then get a digital signature immediately after execution. “This saves time because the particular work steps where paper documentation is needed can now be done in a fully automated way,” adds Bakirci. The electronic system ensures that every step is carried out correctly the first time, and in accordance with regulatory stipulations. The cost of in-house quality assurance is significantly reduced, as is the time needed for later inspections, since attention can now be focused on just the conspicuous data (i.e. “review by exception”). 

PAS-X EBR ensures an error-free and intelligently guided execution of the entire production process, thereby enabling cost-optimized, “right first time” manufacturing. “PAS-X EBR has proven itself with many clients worldwide, improving product and process quality by up to 98 percent from the very first day,” says Bakirci. 

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