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Best-in-Class Workflows and Forms

Title21’s Best-in-Class forms and workflows are flexible to your business processes and facilitate a speedy deployment.

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Personalized Dashboards

Each user’s pending items are organized and prioritized on their personal Dashboard, bringing together all their to-do items in a common location.

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Robust Permission Control

Users’ permissions are managed by power user mode.

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Comprehensive Searches and Queries

Permission-based searching and queries allow users to quickly access the data they need.

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Risk Assessment Tools

Quantitative risk assessment tools are built in to quality forms to facilitate proper prioritization and calculated risk levels of quality events.

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Centralized Reporting

Report on any data captured within the system through predefined reports, or build additional reports based on business needs.

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Compliance & Security

21 CFR Part 11 is achieved through an audit log, compliant e-signatures, complete validation documentation and a robust security model.

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Flexible Delivery Options

Host the solution on Title21’s HIPAA-Compliant Cloud or deploy the solution on premise. Learn More.

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Modular Structure

Each Title21 Solution can stand alone or seamlessly connect to the Title21 EQMS platform allowing for phased deployments based on your priorities.

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Collaboration Tools

Communication with your team across departments and locations is facilitated through collaboration tools in a centralized system.

Eliminate Manual, Paper-Based Quality Processes and Achieve Electronic and Streamlined Quality Management

Easy-to-Use

Easy-to-Use

Title21’s intuitive user-interface is easy to learn, simple to use and brings all relevant data right to your fingertips.

Flexible

Flexible

Title21’s electronic forms and workflows adapt to your specific and changing business needs.

Natively Integrated

Natively Integrated

Each Title21 solution was designed to seamlessly share data and connect processes enabling centralized and closed-loop quality data management.

Go Paperless

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.

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Ensure Compliance and Security

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.

  • 21 CFR Part 11 Compliant
  • Electronic Signatures
  • Full Audit Log
  • Role-based Security Model
  • Permission-based Data Access Control
  • Validation Documentation

Standardize Enterprise-wide Processes and Site-Specific Workflows


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.

Achieve Closed-Loop Quality Management

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.

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