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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 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.

Request a Demo devices
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.

"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.

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Title21's integrated quality management software

On-Premise or Cloud?

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Title21 offers flexible delivery models to meet your needs. Learn More