Quality
Product deviations put your compliance at risk. Regulations require you to fully investigate and document the event. You also need to either resolve it or justify the action. MasterControl product deviation software integrates and automates these tasks, so you stay compliant and on track.
Managing deviations in a timely manner is part of good manufacturing practices (GMP). MasterControl makes it easier to document, investigate, and resolve every product deviation.
Deviation software tracks all routing information and data in deviation forms. Enhanced visibility of events makes it easier for you to stay up to date on issues and avoid delays.
Incomplete investigation records are common audit observations. Deviation management software compiles all record content — both internal and external. It’s stored in a central location. The data is also automatically included as part of the audit trail.
CGMP includes pursuing continuous quality improvement. Deviation management is a core part of quality. By integrating all quality processes, you foster a culture of continual improvement.
Product deviations are best managed as a series of events over time. Integrate deviations with corrective action/preventive action (CAPA), out of specification (OOS), batch record management, etc. to accelerate the closing of quality events. Share data across all business units. Centralize deviation data. Manage deviations as part of your other quality processes, instead of as isolated incidents.
Electronic records have strict document review and approval guidelines. Product deviation software automatically records and tracks deviations and other quality events. The signature and audit trail features make it easy to comply with regulations.
Ensure ongoing compliance by implementing product deviation software.
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