Achieve Paperless and Integrated Quality Management Processes Throughout Your Manufacturing Operations
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.
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Increase Efficiency
Electronic workflows, collaboration tools, and automated approval routing helps you reduce time and costs while improving overall quality.
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Generate CAPAs
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.
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Achieve Closed-Loop Quality Management
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.
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Meet Regulatory Requirements
Title21 solutions support 21 CFR Part 11 including a full audit log, permission-based data access control, validation documentation and more.
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Accelerate ROI
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.
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Manage Staff Training
Ensure effective training plan creation, assignment, execution and documentation with integrated training and learning management tools.
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Streamline Document Control Processes
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.
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Track, Trend, and Report on Actionable Data
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.
"We've been using Title21 since January 2006 and we've been extremely pleased with our increased productivity. Title21 allowed us to virtually eliminate the paper documentation associated with our Device History Record by letting users input the various data directly into the system. Its unique capability to accurately reproduce our paper forms into an electronic version minimizes the training needed for operators to use the system. Plus, we've also implemented Title21 to capture our Return/Repair, Customer Complaint and CAPA systems into a single, comprehensive system that facilitates tracking, linking, processing and trending. Data is maintained in a secure environment and is available with just a few mouse clicks."
Jesse Gasaway RA/QA Director SSCOR, Inc.
Explore Title21's Integrated Solutions for Medical Device Manufacturers
Title21's integrated quality management software provides paperless solutions for all your compliance-driven processes - all in one integrated platform.
