Features that will help you with
your Design History File (DHF) and
your Technical File (TF)
Jira + qmsWrapper
Integration means less mistakes, better control of the development
Integration with Jira adds 5 main advantages:
1. All the projects created in Jira are visible in qmsWrapper’s Project Management Module
3. Issues created in Jira can be seen in qmsWrapper Project
4. A Jira issue can be referenced in the Traceability Matrix.
5. Connect a risk identified with Jira issues in the Traceability Matrix in
a risk-related column.
Traceability Matrix (TM)
The foundation of your FDA Design History File (DHF)
and your CE Mark Technical File (TF).
Key Functions of qmsWrapper Traceability Matrix:
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.
New features of Traceability Matrix:
- 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
- Jira Integration - 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.
Risk Management (RM)
or from the Traceability Matrix.
Two types of Risk Analysis Module were made and the Users can choose
which one suits them more (both built according to the 14971 standard):
1) The Traditional style Risk Analysis (for users who prefer that method) or
2) New Risk Analysis with extensive analyses.
requirements and design, with emphasis on risk-based design. It helps to
document controls that were included in the requirement itself, and by
design, controls a hazard.
Design decisions can now be explained, linked, to how hazards were mitigated
before they became hazards.
1. Form templates made in Form Editor can be attached to any step in
2. Processes can be exported from the Traceability Matrix in PDF.
4. Process categories are now available to create.
5. Changes in processes can be market.
Document Management and Control
User-friendly and team focused Document Management System that works for you, not you for it!
- Audit trail
- Change control
- Security file locking
Cloud Access - from any device, any time
- easy and accessible
- on demand scalability
- secure and fast access
Document Approval WorkflowsSimplify feedback and approval cycles without leaving your platform. Workflows are documented through reports, with full approval history. No confusion, re-work or delays.
Electronic trail and Document ControlTrack, store and control documents to prove compliance
PIN Signature (ERES)Secure and Unique Electronic Document Signatures. Reduce risks, simplify compliance and speed up audits by using ERES and not wasting time on chasing people for signatures.
QMS Processes Driven Project ManagementCreate a full circle of follow-up and coordination for each quality objective, task and issue by driving your Projects through QMS Processes.
QMS Workflow ProcessesReduce errors, forgotten paperwork and missed QMS reports through workflow processes that are not leaving any room for guessing what’s next, steps are defined, monitored and managed by management automatically.
Versioning, Milestones, Roadmaps and Gantt charts to help you see the big picture and understand the project status.
Organize workflows, schedule releases and track which issues relate to different releases of the product.
With the built-in qmsWrapper Workflow Process Editor, you have the freedom to build your own Workflow processes.
“My Team” function shows percentage done, reports and assignments.
The Project Management Module is directly connected to the Risk Management Module to ensure ISO and FDA compliance.
Pick somebody’s brain or get fast answers from a particular colleague in a private 1-1 chat conversation.
Connect your teams and accomplish complex tasks through a campfire, group chats.
Meetings Management - schedule, assign and track.
Every message is archived in the history, files shared or sent in chat are automatically stored in the Central Storage and can be linked to any particular project.