Customer Delight Supports Long-term Partnerships

Title21 Software was founded in 2001 to provide user-centric software solutions to FDA-regulated companies such as medical device, pharmaceuticals, and biologic firms.  Title21’s  decades of experience working with FDA-regulated companies provides Title21 with a unique understanding of  the requirements and a conversant approach. We provide fully configurable solutions to meet your requirements and your specific ways of doing business.

We are a user-centric company that is agile, responsive and fosters long-term partnerships. This is evident in our expandable platform that makes the paperless vision an attainable goal.  Our single focus is to continue to offer the best solution that meets changing business needs and requirements.

Title21 Software products are designed to support various regulatory requirements, from FDA GxP, 21 CFR Part 11 (electronic records and signatures), AABB, CAP and CLIA, including standards such as ISO 9000, ISO 14000, ISO 13485, HIPAA and more. The software suite has been successfully implemented by companies in blood centers, pharmaceutical, biotechnology, medical device, and other FDA-regulated organizations. Title21 Software has received high marks from inspectors and auditors and has supported companies’ efforts to gain pre-market approvals from the FDA.