Non-Conformance Management Software

Streamline Non-Conformance Management and Improve Quality

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.

Ensure Proper Non-Conformance Documentation

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.

Standardize Your Risk Assessment

Built-in risk assessment tools ensure proper immediate action is taken as well as appropriate notification and escalation of the non-conformance.

Accelerate Non-Conformance Resolution

Assign investigation and disposition tasks, collaborate on analysis and electronically route the form for approval, all within the solution’s automated workflow.

Escalate High-Risk Non-Conformances

Escalations and visibility ensure proper managerial notification of high severity non-conformances.

Track and Trend

Categorize the nonconformance by error code, category, department and more to enable tracking and trend analysis of recurring non-conformances and threats to quality.

Report on Actionable Data

Permission-based reporting on real-time and historical non-conformance data keeps you inspection-ready and supports overall quality improvement efforts.

Launch a CAPA

Generate an electronic CAPA form and workflow straight from the nonconformance form, automatically populating common data onto the CAPA.

Download Product Data Sheet file_download

Achieve Paperless, Efficient Non-Conformance Management

Closed Compliance Gaps

Non-conformance data and workflows integrate with other quality solutions creating seamless compliance data management.

Improved Patient Safety

Reduce the quality and safety risks posed by nonconforming products and processes with increased visibility and faster non-conformance resolution.

Paperless Documentation

Automated documentation of your non-conformance management process helps demonstrate compliance to regulatory standards in the event of audits and inspections.

Non-Conformance Management Software

Streamline Non-Conformance Management and Improve Quality

Ensure Proper Non-Conformance Documentation

Standardize Your Risk Assessment

Accelerate Non-Conformance Resolution

Escalate High-Risk Non-Conformances

Track and Trend

Report on Actionable Data

Launch a CAPA

Achieve Paperless, Efficient Non-Conformance Management

Closed Compliance Gaps

Improved Patient Safety

Paperless Documentation

Everything You Need Comes Standard

Flexible Best-in-Class Forms & Workflows

Personalized Dashboards

21 CFR Part 11 Compliant E-Signatures

Searches & Queries

Email Integration

Role-Based Permissions Management

Centralized Reporting

Full Audit Log

Validation Documentation

Security & Data Access Control

Title21 Non-Conformance Solution Natively Integrates with Other Title21 Quality Management Solutions

Title21 Offices