Transforming Diagnostics Manufacturing at Cepheid: Migration from Paper-Based Processes to Digital Manufacturing using Opcenter MES
DOI:
https://doi.org/10.15662/IJRAI.2022.0501005Keywords:
MES, Camstar, Opcenter, eDHR, Digital Manufacturing, GeneXpert KitsAbstract
Manufacturing of GeneXpert® diagnostic kits at Cepheid used to depend heavily on paper documentation. Paper travelers, handwritten entries, and manual checks caused delays, errors, and long review times. To solve these problems, Cepheid implemented Siemens Opcenter (Camstar) MES to move from a paper environment to a digital manufacturing process.
This paper explains how the transition was planned and executed, and how Opcenter improved day-to-day operations, including electronic Device History Records (eDHR), digital work instructions, barcode checks, automated data capture, and real-time quality control. The study covers improvements in accuracy, traceability, operator performance, and compliance. The results show that digital manufacturing provided faster production, fewer errors, and better audit readiness for regulated diagnostics manufacturing.
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