Manage compliance-driven processes though quality management software designed to integrate and inherit data from your clinical and laboratory workflows. All quality data is stored in a central database enabling comprehensive reporting on cell therapy operations and related quality activities.
Manage the full lifecycle of your policies and procedures including creation, collaboration, approval, read-and-sign training, archival and periodic review.
Ensure any changes of processes, supplies, and equipment (that may affect the integrity of the cell therapy product or patient safety) are properly assessed and validated.
Maintain an effective employee training program and manage laboratory competencies with a complete set of LMS tools.
Document, investigate, assess and report nonconforming products and adverse events.
Ensure proper documentation and impact assessment of deviations with electronic signature approvals.
Conduct investigations, perform root cause analysis, and ensure corrective action effectiveness.
Schedule routine audits of your quality system and process controls.
Document the qualification, receipt, handling, storage and track utilization of supplies used in procurement, processing and administration of cell therapy products.
Schedule and track maintenance and calibration activities to monitor critical equipment to ensure proper use of suitable equipment and materials.
Title21's intuitive user interface is easy to learn, simple to use and brings all relevant data right to your fingertips.
Electronic forms and workflows adapt to your specific and changing business needs.
Each solution is designed to seamlessly share data and connect processes enabling centralized and closed-loop quality management.