Title21 Health Solutions
Helping Customers Innovate and Comply in an Evolving Regulatory Landscape

Biotech companies are burdened with the challenge of changing and increasing regulation. Maintaining compliance and proper documentation while adapting to mounting regulatory requirements can hinder innovation and impede operational efficiency. Tackling this challenge is Title21 Health Solutions- a company whose technology manages operational and compliance-driven processes through easy-to-use electronic solutions. “Reliance on manual, paper-based processes such as Access databases and spreadsheets is inefficient and cumbersome, especially in an industry that commands agile and innovative technology” says Lynn Fischer, CEO of Title21 Health Solutions. Title21 Health Solutions offers a comprehensive electronic data management system which helps their customers close compliance gaps, improve quality and overall operational efficiency. “Ultimately, our solutions support our customers to produce innovative new therapies and products that improve patient outcomes,” she adds.

Headquartered in Pleasanton, CA, Title21 Health Solutions offers fully-integrated and flexible solutions to meet the needs of Health Science organizations such as, hospital labs, blood and tissue centers, cellular therapy labs, cord blood facilities and biotechnology companies.

“Organizations in the regulated health science space, such as biotech and pharma, are tasked with the challenge to seamlessly implement electronic processes without disrupting workflow and, in turn, actually realize cost-efficiency as a result of automation,” explained Fischer. “This is only possible with flexible technology that allows organizations to automate and streamline their processes in the way they do business.” Several examples of highly configurable Title21 solutions include CAPA, Audit, and Error Management.

Title21 CAPA Solution intuitively locates the root cause of the nonconformity and establishes thorough follow-up to ensure the correction is effective while taking proactive steps toward making sure a reoccurrence has been prevented. Title21 Audit Solution supports all internal and supplier auditing procedures, while also making the planning and executing of audits efficient and reliable. Title21 Error Management Solution enables clients to track, manage, and analyze the errors and non-conformances.

Title21 offers additional solutions such as Batch Records, Document Control, Training and Learning Management, Equipment Maintenance and Calibration, and more – all on one integrated platform. “At Title21 Health Solutions, we believe natively integrated technology is essential. Our solutions were designed from the ground up to communicate and work with each other,” notes Fischer. Title21 ensures that nothing will “fall through the cracks” as its native integration will close the gaps in an organization’s overall quality program. The technology provides the ability to change processes while maintaining historical process configurations, all without time consuming ‘back-end coding’,making Title21 Health Solutions completely unique in the market.

Powerful, permission-based access within the platform ensures appropriate visibility of data and that users are performing only authorized tasks within the system. Integration with the Training system through the Training and Learning Management Solution prevents users from performing tasks they are not properly trained. Convenient tools such as configurable KPI charts, automatic email notification, trend analysis and reporting provide increased visibility of critical operations and access to quality data.

The future is bright for this rapidly expanding Bay Area technology company. Just this year it released the Title21 Document and Training Portal optimized for tablets, the Title21 Regulation and Standards Maintenance Solution™, as well as announced a new class of technology for Cellular Therapy.

Title21 Cellular Therapy Solution integrates laboratory information management, quality management, and inventory management in one comprehensive platform. “It is a new class of technology in cellular therapy which delivers the possibility of a completely paperless laboratory,” says Fischer. The platform can interface directly with critical laboratory equipment, barcode and labeling solutions, and existing information systems, decreasing double-data entry and increasing interoperability and traceability. “Our innovation and product development is driven by the needs of our customers and the markets we serve. We are dedicated to delivering technology that better enables our customers to make the world a better place, one patient at a time.”