Highlights : About qmsWrapper
Every input in the qmsWrapper Traceability Matrix is organized and shows the details, revisions, history and mapped out relations, from the very beginning of the project.
Requirements are connected to design specifications, to risk analysis, SOPs, test cases, Validation, etc…
Transparent file tracking - trace requirements through the different stages and show they had been successfully addressed.
Get full control of your project! All your CE Technical Files inputs and your FDA Design History inputs, are connected to project tasks, making it easy to complete, easy to update.
Multi-User implementation. All members of your team can work at the same time on the same TM
Risk Assessment can be created from the Traceability Matrix to go feature by feature
link Jira tasks, to testing, testing to validation. Traceability Matrix by qmsWrapper, integrates with Jira, QMS, Project management, Document management, requirements, specifications, design inputs and outputs, testing, life-cycle, making it the core of your DHF and TM, the backbone of your 510k or CE Mark submission.
Product Details
Features
Action plans, analysis, charts, risk reports
Activity dashboard
Audit management
Central Repository
Commenting
Complete Validation For Use Documentation set
Corrective actions (CAPA)
Create and schedule QMS meetings by task, topic or project
Create milestones, versioning, approval workflows
Customizable roles for projects
Document approval workflows
Document management and Control
Drag and drop upload
Electronic Signature
Flexible workgroups
Follow-ups, statistics and investigation
Gantt calendar view
Benefits
Easy to follow up already running processes in Jira.
Traceability Matrix is your dashboard for jor FDA and CE Mark submission.
Better efficiency when multiple users are working at the same time in Traceability Matrix.
Collecting data is straightforward with forms.
Simplified process startup by making the automatically triggered process from one to another.
Secure data management with QMS Vault, ERES, and role based permissions access.
Puts the whole team to work towards compliance (not just the QMS manager).
Easy to use, easy to learn, very intuitive software. Suitable even for “QMS dummies”.
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