TrackWise Digital Cloud QMS

A Complete Quality and Compliance Solution

TrackWise Digital® cloud QMS software is an industry-leading quality management system with integrated modules that work together to support quality, compliance and more efficient decision-making. Built on over two decades of experience, our cloud-based QMS combines best practice processes with the flexibility and scalability of the Salesforce platform.

With reporting and advanced analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance.

WATCH: TrackWise Digital Cloud QMS In Action

Say goodbye to manual processes. You can manage these processes and more from a single, integrated, enterprise quality management system.


Integrated Modules of TrackWise Digital Cloud QMS

TrackWise Digital Cloud QMS allows you to manage core quality and compliance processes in a streamlined manner. With, leverage AI-assisted workflows to automatically suggest categories and correlate complaints and quality events, unlocking the value of quality data and augmenting decisions made by quality teams.

Quality Management

Manage internal, external, and regulatory audits. Initiate planned or unplanned deviations with TrackWise Digital QMS. Conduct risk assessments, identify root causes and initiate and manage CAPAs.

  • Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities
  • Change control process manages changes from request, through pre-approvals, change execution, follow-up approvals and implementation
  • Audit management provides an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle

Complaint Management

Manage the entire complaint lifecycle—from complaint to investigation, root cause analysis and regulatory reporting with our digital quality management system. Track, triage, escalate and share records in a centralized and validated platform.

  • Adverse event reporting (FDA eMDR submission)
  • Configurable questionnaires/decision trees can be used for complaint assessments, reportability assessments and safety assessments

Document Management

Centralize content to promote knowledge sharing and collaboration in a controlled environment with TrackWise Digital QMS.

  • Centralize information on a single platform for quality, regulatory and document management
  • Rule-based, automated workflows with capabilities for review, annotation and approval
  • Maintain compliance by utilizing document controls that ensure everyone is working off a single version of the truth

Training Management

Automate company-wide training policies and regulatory requirements. Training activities are scheduled and tracked through completion, offering proof of compliance with the latest courses and standard operating procedures (SOP).

  • Create and manage training plans for users and groups of users
  • Measure knowledge and understanding using tests and examples
  • Track compliance against due dates to ensure your workforce is trained and audit-ready

Supplier Quality Management

Effectively manage and collaborate with suppliers and contract manufacturers across your supply chain. The Supplier Quality Management application allows quality teams to manage supplier relationships from onboarding to auditing and scorecard analytics.

Other Modules

Why Your Company Needs TrackWise Digital QMS


  • Automate Quality and Compliance Processes
    Ensure your employees adhere to company procedures and external regulations. Eliminate manual systems, improve efficiency and optimize quality and compliance.

  • Leverage AI-Augmented Decision-Making Capabilities applies machine learning and natural language processing to auto-categorize and autocorrelate the intake of complaints and quality events. provides robust solutions to decrease cycle-times, speed up response times, and deliver on customer expectations. 

  • Validate Your Digital QMS Efficiently
    The solution is fully compliant with 21 CFR Part 11, including full audit trail and electronic signature functionality. Each release includes a validation package and supporting documentation.

  • Make Smarter and Faster Decisions
    Self-service dashboards and reports are available on-demand. Make informed decisions based on the most up-to-date quality event information available.



New Features of TrackWise Digital Cloud QMS

Artificial Intelligence with​
TrackWise Digital is the industry's first enterprise QMS with embedded AI-augmented decision making capabilities across the entire QMS. By applying machine learning and natural language processing to complaints and quality events, our cloud-based quality management system can auto-categorize and autocorrelate quality records, driving improved productivity and intelligent decision making across the organization. 

Enterprise-Ready Document Management
TrackWise Digital cloud QMS has expanded collaboration, usability and control features. This includes online collaboration capabilities for multiple document reviewers, flexible permission models for user roles, controlled document download capabilities and seamless integration with other workflows. TrackWise Digital QMS will also support the Salesforce Lightning Experience.

Broader Capabilities for the Medical Device Industry
TrackWise Digital cloud QMS includes support for the European Union Medical Device Regulation (EU MDR), incorporating Manufacturing Incident Report functionality. The cloud-based QMS has industry best practice workflow process and reporting dashboard for integrating risk management and post market surveillance, enabling the shift from reactive to proactive quality management.

See TrackWise Digital Cloud QMS in Action

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