Stop wasting time and jeopardizing your production processes with manual, inefficient paperwork. It’s time for you to take back control of your data with an electronic batch record (EBR) designed to easily track chain of custody and chain of identity for all your units.

One single source of truth for all your products regardless of cell source or clinical stage including Immune Effector Cells (IEC), CAR-T, advanced medicinal products, and other oncologic, non-oncologic, and regenerative medicine biotherapies.
Ensure easy access to the right document at the right time with minimal impact to your IT operations.
Maximize your operational capacity by minimizing stockouts and overstocking, and streamlining production planning.
Streamline both upstream and downstream process development leveraging electronic routing workflows that keep your documents complete, reviewed, and signed off appropriately and accurately across your team.
Facilitate quality across your operations while maintaining the flexibility needed for each location’s site-specific processes and workflows including support for centralized, distributed, decentralized, and point-of-care manufacturing models.
Reduce common slips, lapses and mistakes with smart data fields, instrument and system integration, barcoding, and built-in fail safes.
Maintain complete, auditable records with ease including support for GxP, cGMP, FACT/JACIE, AABB, HIPAA, 21 CFR Part 11 electronic signatures and more.
Gain valuable data-driven insights to accelerate your production timeline.

“We embarked on a comprehensive evaluation of commercial quality system software and after much consideration we decided upon Title21...”

Diane Kadidlo
Executive Molecular and Cellular Therapeutics Facility Director
University of Minnesota

Repurpose your Paperwork

Title21 streamlines your documentation and quality processes so you can focus on delivering more life-saving treatments not more paperwork.

Enterprise Quality Management System (EQMS)

Keep compliance at the forefront by automating and streamlining your staff training and learning, Standard Operating Procedures documentation lifecycle and more.

Manufacturing Execution System (MES)

Easy-to-follow and fully electronic Batch Process Records (EBR) designed to ensure safety, efficacy, and traceability of all your manufactured products.

Solution Overview

Enterprise Quality Management System

Streamline your quality processes, minimize administrative burden, and reduce operational risk with a secure, intuitive, and compliant platform for end-to-end quality management. Download your free Solutions Overview today.

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Ready to Focus More on Patients and Less on Paperwork?

Learn more on how Title21's industry leading biotherapies software solutions can help your facility improve quality and reduce risk.