A Self-Monitoring Quality Management System Incorporating Spectral and Chromatographic Data

Incorporating not only conventional capabilities of sample tracking and LIMS, the new system links the live analytical data to discrete samples in a single database.

The system also carries out comparison and logic testing to further automate the process using software algorithms to make critical decisions about the quality of each sample.

The quality management system has been independently audited, and has been shown to result in a measurable increase in the effectiveness and efficiency of the manufacturing operation. This poster will outline some of the challenges in designing and implementing a system to satisfy the high throughput needs of the operation with minimal manual attendance, and how those challenges were overcome.