Comparison between an E-System and a Paper-based QM System
GMP / GLP / GCP
is a pharmacist. She studied international finances and law at the Dalian Maritime University in China and pharmacy at the University of Erlangen-Nürnberg. After finishing her studies, she worked in QA, QC and Regulatory Affairs for various companies such as Aug. Hedinger, Stuttgart and ratiopharm, TEVA Ulm.
The author compared an electronic QM system, e.g., TrackWise®, with the paper-based QM system based on seven aspects (validation, audit trail, legacy systems, copy and retention of records, data trending analysis, cost and usability).
The score is ranging from three stars (maximum of points) to a minimum of zero stars. A star is (...)