Project Management with qmsWrapper
for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success
Get things done! Track, Manage and organize your projects and your teams!
We invented qmsWrapper because we needed what you need: a system to help get your projects done on time and stay FDA or ISO compliant.
To do this we created an integrated software that included five main modules:
- Project Management,
- Document Management & Control,
- Quality Management,
- Risk Management
- Traceability Matrix and
- Team Messaging.
They are separate so you can work within each module as needs arise but, they are highly integrated and interconnected to maximize productivity and provide a seamless team based compliance experience.
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.
- Clear accountability, flexible workgroups with customizable roles by project.
- 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.
- Defined QMS workflow processes can jump-start your project—they make ISO 13485 and FDA QSR compliance easier.
- With the built-in qmsWrapper Workflow Process Editor, you have the freedom to build your own Workflow processes to suit your specific project or QMS needs.
- Documents are controlled and stored according to their respective projects, which makes it easier for the Team to find.
- The Dashboard provides a detailed, real-time visual overview of all the users tasks, reports and assignments, to help them keep track of milestones, QMS issues, deadlines, upcoming events, to-dos and due dates at a glance.
- For real-time visual overview of all user tasks, there is a “My Team” function, that shows percentage done, reports and assignments. You can monitor who does what, with what efficiency. You can instantly identify any overlaps in the work and easily reassign tasks as needed, follow the over-all productivity and keep track of them.
- Projects in the Project Management Module are mirrored in both the Document Management Module and the Quality Management module where all QMS events for any project can be followed, monitored, and tracked by the QMS Manager. Also, with the QMS approval workflows, automatic notifications are sent to the QMS Manager for action.
- Built-in Team Messaging is designed to support Team compliance. Messages and files included in chats can be linked into particular projects or tasks -- the simplest way to document any issue. For Compliance purposes, you should save any Chat as a meeting to a particular project complete with follow-up actions. Remain one step closer to full compliance.
- The Project Management Module is directly connected to the Risk Management Module to ensure ISO and FDA compliance.
qmsWrapper is team collaboration and cooperation, FDA and ISO 13458 compliance and project productivity all wrapped into one.
Managing Through Quality (MTQ)
The new science of Managing for Compliance
QMS focuses on quality outcomes, but Managing Through Quality (MTQ) is about managing through the QMS Workflow Processes that lead to those quality outcomes.
In qmsWrapper, Quality Management is integrated with Project Management, Document Management, Risk management and Team Messaging rather than implemented as a separate management layer – in other words, QMS is sewn into the very fabric of qmsWrapper.
This level of QMS integration means QMS Workflow Processes interact and inter-connect with all parts of qmsWrapper, thereby making MTQ possible.
The integrated Team Messaging ensures everyone works together towards those quality outcomes fostering a culture of team based compliance.
MTQ cultivates Good Management Practices (GMP) by encouraging good team work using quality outcomes to unite them in the innovative science of Managing for Compliance.
Give qmsWrapper a try and streamline the way you approach compliance
If you have any questions, or there’s anything we can do, please contact us through firstname.lastname@example.org
The qmsWrapper Team.