Title21 provides easy-to-use and flexible software to support medical device companies to deliver compliance, generate efficiencies and improve overall quality. Developed using firsthand experience in medical device quality assurance, Title21 provides the tools to help medical device organizations reach operational goals efficiently with one centralized platform for quality data management.
Electronic workflows, collaboration tools, and automated approval routing helps you reduce time and costs while improving overall quality.
Document all non-conformances, deviations and errors while ensuring timely resolution through risk assessment tools and the ability to launch a CAPA from your error form.
Title21’s solutions natively integrate on a common platform, enabling integrated processes and a single interface and database to manage all your compliance-driven data including document control, CAPA, audit and training.
Title21 solutions support 21 CFR Part 11 including a full audit log, permission-based data access control, validation documentation and more.
Title21 Best-in-Class Forms and Workflows are flexible, out-of-the box solutions that can be deployed quickly with minimal impact to your IT Operations. Title21 offers both HIPAA-compliant private cloud and on-premise installation options to support both small and multi-site firms.
Ensure effective training plan creation, assignment, execution and documentation with integrated training and learning management tools.
Simplify the revision and approval process of controlled policies, procedures and SOPs with Title21 Document Control, complete with periodic review, change control and read-and-sign training.
Perform trend analyses and run real-time reports on quality data throughout your operations to increase visibility of potential compliance risks and promote continuous quality improvement.
Title21's integrated quality management software provides paperless solutions for all your compliance-driven processes - all in one integrated platform.