Title21 Health Solutions is a provider of electronic quality management and manufacturing software for the healthcare and life sciences industries. Title21 Health Solutions offers an end-to-end platform that enables organizations to digitize and automate critical processes like electronic batch records, blood and marrow transplant workflows, and enterprise quality management systems (EQMS), aiming to support a paperless manufacturing environment.
Title21's flexible system is designed to help organizations manage complex protocols while maintaining regulatory compliance. The platform supports a wide range of digitized processes, including:
- Manufacturing record management
- ISBT 128 labeling for blood products
- Supplies and reagents tracking
- Equipment maintenance scheduling
- Chain of custody management
- Finished product inventory
- CIBMTR/AGNIS integration for transplant data
- Outcomes analytics
- QC/LIMS system integration
These features are intended to streamline and standardize data capture, support compliance, and drive operational efficiency in highly regulated healthcare settings.
Who Uses Title21 Health Solutions?
Title21 Health Solutions primarily serves leading hospitals, research centers, blood banks, and transplant programs. Notable customers include Mayo Clinic, Memorial Sloan Kettering Cancer Center, Stanford Health Care, Penn Medicine, Fred Hutch Cancer Research Center, Kaiser Permanente, University of Minnesota, Miller-Keystone Blood Center, Cleveland Cord Blood Center, and ImpactLife. These organizations rely on Title21’s software to digitize and manage complex manufacturing and clinical processes.
How Was Title21 Health Solutions Started?
Title21 Health Solutions was founded by professionals with extensive experience in clinical operations, commercial leadership, and the healthcare sector. Key members include Jonathan Wofford (Chief Commercial Officer), Heather Purvis (Director of Clinical Operations), Diane Kadidlo (University of Minnesota), Abe Garcia (Miller-Keystone Blood Center), and Macie Finney (Cleveland Cord Blood Center). Their backgrounds reflect a focus on bridging technology and clinical practice to advance digital transformation in healthcare manufacturing and quality management. More information about the company’s background and team can be found on their About page.
What Makes Title21 Health Solutions Distinct?
Title21 Health Solutions differentiates itself through its comprehensive and flexible platform, which is tailored to meet the needs of organizations handling complex manufacturing and compliance requirements. Its ability to support a fully paperless environment, integrate with industry standards (such as ISBT 128 and CIBMTR/AGNIS), and serve leading healthcare institutions underscores its specialized market position.
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