OOS Management

Evaluating suspect or out-of-specification (OOS) test results that fall outside the specifications or acceptance criteria for active pharmaceutical ingredients and finished products is mandated by FDA's cGMP guidelines and is a key responsibility of the laboratory and quality personnel in a pharmaceutical company. As the integrity of laboratory testing and documentation records is of fundamental importance for a drug manufacturing operation, quality managers need a powerful automation and collaboration solution to successfully handle OOS incidents as a close-loop assessment, investigation and reporting process spans across departments and locations.

MetricStream OOS Management is a comprehensive solution that enables companies to establish and follow consistent procedures for managing OOS incidents. The module supports identification, assessment, investigation and reporting of OOS cases along with the ability to track each case. The powerful analytics and reporting capability with graphical dashboards give managers complete real-time visibility into the OOS data and provide critical information for executing corrective/preventive actions.