Title21 Non-conformance Solution is web-based non-conformance management software designed to support health sciences organizations achieve timely documentation, escalation and resolution of non-conformances – helping maintain quality and ensure patient safety.
Standardized forms and electronic workflows ensure required data is collected from initial reporting of the non-conformance through evaluation, investigation, analysis, corrective action planning and approval.
Built-in risk assessment tools ensure proper immediate action is taken as well as appropriate notification and escalation of the non-conformance.
Assign investigation and disposition tasks, collaborate on analysis and electronically route the form for approval, all within the solution’s automated workflow.
Escalations and visibility ensure proper managerial notification of high severity non-conformances.
Categorize the nonconformance by error code, category, department and more to enable tracking and trend analysis of recurring non-conformances and threats to quality.
Permission-based reporting on real-time and historical non-conformance data keeps you inspection-ready and supports overall quality improvement efforts.
Generate an electronic CAPA form and workflow straight from the nonconformance form, automatically populating common data onto the CAPA.
Non-conformance data and workflows integrate with other quality solutions creating seamless compliance data management.
Reduce the quality and safety risks posed by nonconforming products and processes with increased visibility and faster non-conformance resolution.
Automated documentation of your non-conformance management process helps demonstrate compliance to regulatory standards in the event of audits and inspections.