Title21’s EQMS is an end-to-end quality management software system that provides integrated and scalable solutions for automating workflows, integrating compliance-driven processes and fostering continuous quality improvement.
Title21’s Best-in-Class forms and workflows are flexible to your business processes and facilitate a speedy deployment.
Each user’s pending items are organized and prioritized on their personal Dashboard, bringing together all their to-do items in a common location.
Users’ permissions are managed by power user mode.
Permission-based searching and queries allow users to quickly access the data they need.
Quantitative risk assessment tools are built in to quality forms to facilitate proper prioritization and calculated risk levels of quality events.
Report on any data captured within the system through predefined reports, or build additional reports based on business needs.
21 CFR Part 11 is achieved through an audit log, compliant e-signatures, complete validation documentation and a robust security model.
Host the solution on Title21’s HIPAA-Compliant Cloud or deploy the solution on premise. Learn More.
Each Title21 Solution can stand alone or seamlessly connect to the Title21 EQMS platform allowing for phased deployments based on your priorities.
Communication with your team across departments and locations is facilitated through collaboration tools in a centralized system.
Title21’s intuitive user-interface is easy to learn, simple to use and brings all relevant data right to your fingertips.
Title21’s electronic forms and workflows adapt to your specific and changing business needs.
Each Title21 solution was designed to seamlessly share data and connect processes enabling centralized and closed-loop quality data management.
Eliminate manual processes and frustrations with a truly paperless software system. With less time spent managing paper and manually integrating data, you can focus on improving quality, reducing risk and delivering products and services that make a difference.
Title21 offers a complete platform of integrated quality and compliance management solutions – all within a single software suite. Each solution listed below can be deployed alone, simultaneously, or in a phased approach to ultimately deliver complete quality management through a single comprehensive system.
Title21 Solutions were designed to support compliance requirements as outlined in regulations and standards of health sciences organizations, including FDA, ISO, HIPAA, CLIA, CAP, AABB, and more. Accurate documentation, complete traceability, and prompts to stay up-to-date on compliance activities support your program's inspection readiness.
Title21’s EQMS is designed to facilitate quality across the enterprise while maintaining flexibility for each location’s site-specific processes. This enables multiple sites to operate on a common platform, while maintaining workflows and processes specific to their location. Robust permission controls ensure that each site has access to what they need while providing centralized management, reporting and oversight at the enterprise-level.
Title21 quality management solutions can share data seamlessly because they are built on a common platform. If a quality event, such as a customer complaint or a non-conformance, requires a CAPA, an electronic CAPA form can be launched right from the initiating event and pre-populate common data. If a change in a procedure is required by the CAPA implementation plan, it can be linked and launched directly from the electronic CAPA form through the Document Control Solution. When the revised SOP is approved, read-and-sign training can be issued and managed – all within a single platform.Request a Demodevices