Title21 Deviation Management Solution is Deviation Management Software that supports healthcare and life sciences organizations to document and manage planned and unplanned deviations while maintaining compliance and ensuring high quality operations.
Standardized forms and electronic workflows ensure required data is collected from initial documentation of the deviation through investigation, analysis, and resolution.
Built-in risk assessment tools ensure proper immediate action is taken as well as appropriate notification and escalation of the deviation.
Document planned deviations with justification information and route for managerial approval within the system.
Assign investigation tasks, collaborate on analysis and electronically route the deviation form for approval, all within the solution’s flexible workflow.
Identify trends and patterns of deviation occurrence through tagging and tracking error codes, categories, departments and more.
Automated Escalations ensure proper managerial notification of high severity deviations.
Permission-based reporting on real-time and historical deviation data keeps you inspection-ready and supports overall quality improvement efforts.
Generate an electronic CAPA form straight from the deviation form, automatically populating any common data onto the CAPA.
Link deviations to related quality forms including non-conformance, CAPA or customer complaints.
Ensure all data required for cGMP guidelines is captured on the deviation record.
Automated workflows and intuitive electronic forms facilitate efficient and streamlined deviation processes.