Variance Management

Recording and investigating any process deviations from established manufacturing procedures is mandated by FDA's cGMP guidelines and is a key responsibility of the quality personnel in the FDA regulated industry. Documenting and investigating deviations is of fundamental importance for a drug manufacturing operation to maintain consistent product quality and to lower the risk of nonconformance. Quality managers need a powerful automation and collaboration solution to successfully handle incidents of deviations as a closedloop process that spans across departments and locations.

MetricStream Variance Management is a comprehensive solution that enables companies to establish and follow consistent procedures for managing deviations. The module supports documenting, reviewing, approving, investigating and reporting of deviation incidents 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 deviations data and provide critical information for executing corrective/preventive actions.