The consequences of microbiological contamination range from FDA warning letters through product quarantines and recalls all the way to plant shutdowns. This makes quality control, specifically microbiological and environmental monitoring (EM) a mission-critical priority for pharmaceutical and biotechnology drug manufacturing operations.
Are you currently struggling with integrating a home-grown, paper-based or semi-automated EM system to your LIMS only to find out that it’s error-prone and resource hungry? Are your current LIMS or IT systems over extended when it comes to customizing automated, paperless, mobile data capture and workflow management for EM? Are you searching for a proven, best-practices approach to automate EM and LIMS workflows and reporting in a cGMP environment without hindering new product development and production?
This whitepaper provides an overview of the essential workflow steps for implementing a paperless, automated, end-to-end environmental monitoring solution to increase productivity, reduce compliance risk and generate a healthy return on investment.