Maintain a Quality System that Meets the Requirements of FDA, AABB, and FACT Standards

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.

Document Control

Manage the full lifecycle of your policies and procedures including creation, collaboration, approval, read-and-sign training, archival and periodic review.

Change Management

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.

Training Management

Maintain an effective employee training program and manage laboratory competencies with a complete set of LMS tools.

Non-Conformance Management

Document, investigate, assess and report nonconforming products and adverse events.

Planned and Unplanned Deviations

Ensure proper documentation and impact assessment of deviations with electronic signature approvals.

Corrective & Preventive Actions

Conduct investigations, perform root cause analysis, and ensure corrective action effectiveness.

Audit Management

Schedule routine audits of your quality system and process controls.

Supplies Management

Document the qualification, receipt, handling, storage and track utilization of supplies used in procurement, processing and administration of cell therapy products.

Equipment Maintenance & Calibration

Schedule and track maintenance and calibration activities to monitor critical equipment to ensure proper use of suitable equipment and materials.

Quality Management for Cell Therapy Organizations

Maintain a Quality System that Meets the Requirements of FDA, AABB, and FACT Standards

Document Control

Change Management

Training Management

Non-Conformance Management

Planned and Unplanned Deviations

Corrective & Preventive Actions

Audit Management

Supplies Management

Equipment Maintenance & Calibration

The Only Cell Therapy Software with a Built-in, Comprehensive QMS

Easy-to-Use

Flexible

Natively Integrated

Explore the natively integrated modules of the Title21 Cellular Therapy Solution

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