qmsWrapper PM & QMS Software

4.5 / 5 3 reviews

Who Uses This Software?

Medical device manufacturers, startups who are facing unique challenges with Design Control and Risk Management, and seek to achieve CE mark, FDA 510k or ISO 13485:2016 standard compliance.

Average Ratings

3 Reviews
  • 4.5 / 5
  • 4.5 / 5
    Ease of Use
  • 4.5 / 5
    Customer Service

Product Details

  • Starting Price
  • Free Version
  • Free Trial
  • Deployment
    Cloud, SaaS, Web
  • Training
    Live Online
    In Person
  • Support
    24/7 (Live Rep)

Vendor Details

  • qmsWrapper
  • www.qmswrapper.com/
  • Founded 2015
  • Canada

About This Software

qmsWrapper for achieving & maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper integrates 5 separate software into 1 complete cloud based system, including Project, Risk, Document and Quality Management modules with built-in Team Messaging for the best Collaborative Compliance experience. Quality managers with little experience can easily step into the role and effectively start. Create safer, better, medical devices and get them to market faster.

qmsWrapper PM & QMS Software Features

  • Budget Management
  • Bug Tracking
  • Collaboration
  • File Sharing
  • Gantt Charts
  • Idea Management
  • Issue Management
  • Milestone Tracking
  • Percent-Complete Tracking
  • Portfolio Management
  • Project Planning
  • Requirements Management
  • Resource Management
  • Status Tracking
  • Task Management
  • Testing / QA Management
  • Time & Expense Tracking

qmsWrapper PM & QMS Software Reviews

Smartest QMS with integrated Project & Document management for easy FDA/ISO compliance. Easy. Simple

Sep 22, 2016
5 / 5
Ease of Use
4 / 5
Features & Functionality
4 / 5
Customer Support
5 / 5
Value for Money
Likelihood to Recommend: Not

Pros: The processes. You don't have to learn everything about ISO or FDA QSR. Choose a Process and follow the steps. once QMS roles are defined the process knows how to assign the next task.
The chat... sure there is Slack, but this chat is integrated into the projects and is loaded with compliance features. Automatic minutes, agenda, meeting scheduling... tasking from withing a meeting,
they included the validation documentation I needed for FDA "intended Use" testing. this saves hundreds of hours of work (they say 423, but I think its low).
its affordable - the value is incredible.
they have WrapperApp, which is desktop file saving app that is fully connected to the projects. You actually forget to use the Document storage module when creating word and excel files because you save in wrapperApp and it sync's it with the project. Love this feature!

Did I say processes.! They just released a process editor so i can make my own processes and edit the existing ones. This is fantastic because now we use 6 different CAPA processes for different uses ending with different forms. Never thought it would be so easy.
The biggest pro, is that it was really easy for the team to use. very low learning curve.

Cons: Its not a complete a project management software as dedicated competitors. I'd say it has only about 85% of all the bells and whistles of the all PM competitors. But the QMS stuff really outweights the cons here... we really don't miss those little features... sure they are cute, but they are not essential.
You have to buy additional storage space separately and we need a lot but prices are comparable to drop box.
Dashboard is clunky. good if you do a lot of To-dos, but the developers window is hidden below the horizon. could be better.
Wish I could open many conversations at a time and switch between them. now I have to open different browser sessions.

Overall: After we got our first FDA approval, we realized we needed to make changes, not only to how we worked but how we implemented compliance. We wanted to combine as much of the project tasks as we could with QMS compliance without always duplicating the work and having developers chase QMS forms between tasks. I also desperately wanted to reduce emails and move away from Skype, where we realized that many of our ideas and shared documents were not included in the related project. Developers often forgot to move them and save them and annotate them so they were not orphaned in Skype or Email.
qmsWrapper's chat module is connected to project and document management which is all integrated with the QMS system. Overnight, email usage dropped 90% - at least. CHats were connected to projects, and their meeting feature meant you could save chats as official compliance meetings. Documents in chat are actually stored in the projects and managed through the storage or document manager.
In a single day, everyone was using it... Sure, i had to configure it but that was not long either once i understood how QMS Roles and Permissions worked - it was not so strange as it was like in the ISO. The system is setup as a project management system similar to many others out there... but it runs on QMS processes... which are a series of tasks that force your team to follow all the ISO steps... including adding next steps and who to give the next tasks to. And if a form is involved you cannot finish the project task without completing the QMS form.
the coolest feature is the QMS module. it essentially mirrors the projects but includes all the QMS events or reporting points. I can monitor the status of all projects easily without opening each project. This they call managing through quality and it works. My job is a lot easier as a result.
the document management does what a document manager is supposed to do. versioning, history, but 2 features really stood out. QMS document approval, ok, nothing special in itself, except it is reported through QMS and requires the approver to approve through their unique PIN number. This Pin Signature is great for identifying the actual approver and the pin follows the document. the other great feature was QMS Vault, here fully approved and final documents were permantly stored with its history. its unchangeable and undeletable.
Last, its an online service which made it easy to deploy.

Recommendations to other buyers: Use the trial version first. this helped us configure the setup we eventually wanted. Problem was we wanted to go from trial version to paid version with more users, but had to reenter the data. Pain, but they are working on it.

Vendor Response

by qmsWrapper on October 10, 2016

We made our product for Startups and App teams, so they don┬┐t have to learn and know every little detail about ISO 13485:2003-2016 and FDA QSR 21 regulations. The use of the software is easy. The learning curve is really small compared to other software usage. New QMS managers can pick up fast on the regulations from the QMS processes in the qmsWrapper. Even the team collaboration tool has a twist to foster standard compliance in a company. We are continuously changing the dashboard appearance so it would fit our users needs. It will be a lot better organized soon. As for the conversation windows, duly noted, we will try our best to fix that as well.