SmartLab EM offers paperless environmental monitoring

Published: 28-Jul-2011
Analysis Digital

Reduces errors and the risk of batch rejection in aseptic processing


VelQuest, a US developer of specialist software for the pharmaceutical industry, has developed SmartLab EM, a paperless microbiological environmental monitoring system for pharmaceutical and medical device manufacturers.

The management software was developed in collaboration with some of the largest pharmaceutical companies who were seeking a paperless system that would reduce errors and the risk of batch rejection in aseptic processing facilities.

FDA Good Manufacturing Practice (GMP) regulations require manufacturers to include microbiological and environmental monitoring data with product batch release documentation. Paper-based management, collection and reporting of this data can be problematic. Errors could mean compliance deviations, delayed product release and batch rejection.

SmartLab EM manages site plans, sampling schedules, workflow, resources, bar code labelling and scanning, sample tracking, and trend reports.

VelQuest is a privately held company founded in 1999 and is based in Hopkinton, MA, US.

  • Companies:
  • VelQuest Corporation
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