Integrated Modules of TrackWise Digital Cloud QMS
TrackWise Digital Cloud QMS allows you to manage core quality and compliance processes in a streamlined manner. Leverage machine learning and natural language processing to auto-categorize the intake of complaints and quality events.
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
TrackWise Digital QMS applies machine learning and natural language processing to auto-categorize the intake of complaints and quality events. This supports improved productivity and intelligent decision making across the organization.
- 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
AI Capabilities
TrackWise Digital cloud QMS is the industry's first enterprise QMS with embedded AI-augmented decision-making capabilities. By applying machine learning and natural language processing, our cloud-based quality management system can auto-categorize the intake of complaints and quality events, 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 EU MDR 2020, incorporating Manufacturing Incident Report functionality. The cloud-based QMS has industry best practice workflow process and reporting dashboard for risk management, enabling the shift from reactive to proactive quality management.