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Features that will help you with
your Design History File (DHF) and
your Technical File (TF)

 

 

 

 

 

Jira + qmsWrapper

qmsWrapper was designed to Wrap a QMS comfort blanket around Jira,
and broaden the benefits of Jira into the medical device world.

 

 

Together, Jira and qmsWrapper, make an Agile combination.

Integration means less mistakes, better control of the development
process.

Integration with Jira adds 5 main advantages:

1. All the projects created in Jira are visible in qmsWrapper’s Project Management Module
 
2. Connect Existing or New projects created in qmsWrapper with Jira
project.

3. Issues created in Jira can be seen in qmsWrapper Project
Management Module.

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:

Organize
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.
Connect
Requirements are connected to design specifications, to risk analysis,
SOPs, test cases, Validation, etc…
Trace
Transparent file tracking - trace requirements through the different
stages and show they had been successfully addressed.
Manage
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)

Complete Risk Assessment Aligned with ISO 14971

 

 

Risk Assessment is a separate module; it can be created separately
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.
Upgraded (new) Risk helps the user to focus on the relationship between
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.

Process Engine

Transforming qmsWrapper from a task-based engine to Processing Engine

 

 

Added to Process Editors functionality:

1. Form templates made in Form Editor can be attached to any step in
the workflow.

2. Processes can be exported from the Traceability Matrix in PDF.
3. Processes can be triggered directly from within the TM.

4. Process categories are now available to create.

5. Changes in processes can be market.

Document Management and Control

Track, Manage, Store and Bring Company Content Under Control

 

 

qmsWrapper Document Management System is designed to support compliance, it includes version control, detailed file histories, file tracking, source tagging, comments, authority control.

User-friendly and team focused Document Management System that works for you, not you for it!
  • Stamps
  • Audit trail
  • Change control
  • Security file locking
  • Permissions

Cloud Access - from any device, any time

  • easy and accessible
  • on demand scalability
  • secure and fast access

Document Approval Workflows

Simplify 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 Control

Track, store and control documents to prove compliance
  • Versioning
  • Tagging

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.

Quality Management

U.S.QSR (21CFR 820) for 510(K), CE Mark and ISO 13485:2016 Compliance Made Easy

 

 

QMS Processes Driven Project Management

Create a full circle of follow-up and coordination for each quality objective, task and issue by driving your Projects through QMS Processes.
MTQ helps to coordinate, control and direct your organization’s tasks and activities, to help you not only meet your customer’s quality requirements but also your regulatory and compliance requirements.

QMS Workflow Processes

Reduce 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.
In qmsWrapper, Quality Management is integrated with Project, Document and Risk management - in other words, QMS is sewn into the fabric of each module.

Project Management

Track, Manage and organize your projects and your teams!

 

 

The Project Management module has everything you need to organize, create and manage projects: plan it, track it, discuss it, act on it. Divide projects into manageable parts, subprojects, and tasks.

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.
The Dashboard provides a detailed, real-time visual overview of all the users tasks, reports, and assignments.

“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.

Team Messaging

Integrated into all the Modules to Support your Project Development
and Compliance Activities

 

 

Track project changes, capture meetings, flag QMS and design changes across all the software modules.

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.
Execute faster across distributed teams using topic-based, ongoing discussions with the full context of the work.

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.