Our History

Founded in 2001, Title21 was named after the regulatory code governing the food and drug industries in the United States (Title 21 of the Code of Federal Regulations). From the beginning, our focus has been on helping healthcare and life sciences organizations navigate the intricacies of regulatory compliance and quality management.

Over the years, we have evolved and expanded our offerings to meet the growing needs of the healthcare industry. Today, Title21 is recognized as a leading quality management and electronic batch process record software provider to cellular therapy laboratories, blood and marrow transplant programs, and biotherapeutic manufacturers. Used by some of the nation’s most prestigious healthcare institutions, Title21 understands the unique nuances affecting this industry. We are dedicated to streamlining and enhancing the documentation process by providing innovative and automated tools that allow our clients to focus on delivering life-saving treatments not manual paperwork.


Founded with a focus on quality management exclusively in the FDA-regulated health sciences.


Heath Care Sites with Title21's all-in-one technology improving quality, efficiency, and access to world-class care and biotherapies.


Years cell therapy expertise to support clinical workflow and manufacturing solutions.

Our Mission

Title21 believes biotherapies are the future of medicine and the industry needs higher quality and better access to tools and data to discover and deliver cures to patients. Our role is to design and implement software that bridges the gap between clinical practice, laboratory science, and therapeutic manufacturing, empowering our customers to serve patients with quality, efficiency, and kindness in mind. Ultimately, Title21 is proud to enable and enhance the execution of workflows and the collection and presentation of data that lets our customers tell their stories and serve their patients.

Our Commitment to the Future

As the healthcare landscape continues to evolve, Title21 remains committed to being at the forefront of innovation. We are dedicated to investing in research and development, expanding our product offerings, and partnering with healthcare organizations to create a brighter, healthier future for all.

Join Our Team of Innovators

We're a community of problem-solvers and collaborators dedicated to bringing innovative software solutions to patients globally. If you're ready to use your unique talents and make a real impact, explore our open positions and discover a career where your contributions truly matter.