About qmsWrapper

qmsWrapper is a smart management software that effectively avoids adding another layer of management by encouraging team-based collaboration compliance.

It helps all companies that want to increase productivity with ISO 9001:2015 and medical device creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820.

This software is intended for all companies needing a powerful, unified platform to help the team work more effectively together.

qmsWrapper integrates Quality, Documentation, Project and Risk Management and Team Communication, all built right into its DNA. Check all of our features on: https://www.qmswrapper.com/features

Who is it for?
1. For companies who need guidance to implement and adopt validated QMS
2. For companies who want to automate their quality management and go beyond a paper-based system.

Integration with JIRA
This integration helps medical device companies to have a combination of the best Agile development system and the best QMS system.

Choose your QMS:
1. eQMS for MedDev
2. eQMS: ISO 9001

Basic package includes:

25 Users + 1GB Storage
Additional Storage possible up to 500GB.
1GB per $18,00
Quality Manual FREE

Key benefits of qmsWrapper

• Simplified process startup by making the automatically triggered process from one to another.

• Quality Management and Project Management are integrated into one software.
Eliminates the need for multiple software applications and separate, “bolt-on” quality systems.

• With the Quality Manual Builder Tool and a complete Validation For Use Documentation set, qmsWrapper can save hundreds of hours of team’s time on compliance documentation.

• Collecting data is straightforward with forms.

• Comprehensive Document Management & Control with File version control, detailed histories, tracking, tagging, comments and authority control. Stop the QMS Paper Chase!

• Secure data management with QMS Vault, ERES, and role based permissions access.

• Built-in Team Messaging – that has compliance built into its DNA to help foster and support team based regulatory compliance.

• 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”.

• Easy to follow up already running processes in Jira.

Devices

Business size

S M L

Markets

Canada, United States

Supported Languages

English

Images

Process Framework
Create Task
Process
QualityManual
Risk Management
Traceability Matrix
View 7 more
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qmsWrapper screenshot: Process Framework qmsWrapper screenshot: Create Task qmsWrapper screenshot: Process qmsWrapper screenshot: QualityManual qmsWrapper screenshot: Risk Management qmsWrapper screenshot: Traceability Matrix

Features

Total features of qmsWrapper: 89

  • Access Controls/Permissions
  • Activity Dashboard
  • Activity Management
  • Activity Tracking
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Assignment Management
  • Audit Management
  • Audit Trail
  • Automatic Backup
  • Blended Learning
  • Bug Tracking
  • Calendar Management
  • Change Management
  • Chat/Messaging
  • Collaboration Tools
  • Commenting/Notes
  • Communication Management
  • Communications Management
  • Complaint Management
  • Compliance Management
  • Configurable Workflow
  • Conversion Tracking
  • Corrective and Preventive Actions (CAPA)
  • Customizable Reports
  • Customization
  • Data Capture and Transfer
  • Data Import/Export
  • Data Synchronization
  • Deadline Management
  • Defect Tracking
  • Design Management
  • Digital Signature
  • Disaster Recovery
  • Document Coding & Control
  • Document Management
  • Document Review
  • Document Storage
  • Drag & Drop
  • Electronic Signature
  • Equipment Management
  • FDA Compliance
  • File Management
  • File Sharing
  • Gantt/Timeline View
  • Historical Reporting
  • ISO Standards Management
  • Indexing
  • Issue Management
  • Issue Tracking
  • Knowledge Base Management
  • Maintenance Management
  • Milestone Tracking
  • Multiple User Accounts
  • Prioritization
  • Process Control
  • Product Data Management
  • Progress Tracking
  • Project Management
  • Project Tracking
  • Project Workflow
  • Projections
  • Quality Assurance
  • Quality Control
  • Real Time Notifications
  • Real Time Reporting
  • Reporting & Statistics
  • Requirements Management
  • Risk Analytics
  • Risk Assessment
  • Risk Management
  • Role-Based Permissions
  • SSL Security
  • Search/Filter
  • Secure Data Storage
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Tagging
  • Task Management
  • Task Progress Tracking
  • Third Party Integrations
  • To-Do List
  • Traceability
  • Training Management
  • Version Control
  • Web Forms
  • Workflow Management

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Reviews

Overall rating

4,6 /5
(12)
Value for Money
4,4/5
Features
4,1/5
Ease of Use
4,1/5
Customer Support
4,7/5

Already have qmsWrapper?

Software buyers need your help! Product reviews help the rest of us make great decisions.

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Showing 5 reviews of 12
Marina V.
Overall rating
  • Industry: Information Technology & Services
  • Company size: 201-500 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

Reviewed on 2017/06/28

Jonathan E.
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Daily for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

Very happy to have found, even happier to recommend!

Reviewed on 2017/09/06

Project management + QMS
Processes to guide you through regulations
Templates to populate
Massively...

Project management + QMS
Processes to guide you through regulations
Templates to populate
Massively cost saving
Wonderful account management
Automated Quality Manual with a gap analysis report

Pros

My company came from MasterControl; we found it hard to use, expensive, and essentially a giant version control system that was quite dated. For a long time we have to run project management separately in Asana, increasing our workload and, even after expensive MasterControl training, leaving us wondering what to do to get our medical device through the certification process.

Then I found QmsWrapper

QmsWrapper is not only a QMS system and a Project Management tool, but it actually has the processes and templates required to get you through ISO 13485 and an FDA510k build directly into it.
This was clearly made by people who have not only been through the process, but recognised how hard it was and the need for a system to help guide one through it.
Their support reflects this, as they understand your needs and go above and beyond helping you.

The processes explain what you need to do, step by step, giving you templates to download, populate, and upload back into the system.

Auditors don't just want to see that you have said you are going to do something, they want proof that you have done it - using QmsWrapper to do your project management, host your meetings, and have conversations in its inbuilt chat program, provide you with just that - proof.

It even has an inbuilt quality manual that you configure to your companies needs. You can then run a gap analysis from what you have said you're going to do, and what you have actually done, to find the holes.

Cons

They need a new desktop sync tool, which I believe they are working on, but the biggest issue with the system is that it does not interface with your local calendar.

Meetings have to be scheduled all the time, with people on the go, and one must consider that the entire team does not sit in the system.

It could also do with a traceability matrix, and better training videos / manuals. My account manager has been fantastic in lieu of this, and I have it on good faith that the matrix is on its way this month.

Metehan A.
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Monthly for Free Trial
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 0.0 /10

Outdated Software

Reviewed on 2020/12/09

Pros

Easy to understand, Helpful team, Quick response and availability

Cons

The software is outdated, its like an improved excel sheet, We are using jira/confluence day to day basis and qms wrapper is not even matching with them

Response from qmsWrapper

We appreciate your feedback. We are pleased that we were of help to you while being on the free trial but sad to hear you haven't given it a chance in a proper way. Regards the spreadsheets, they are only used in TM that is used for design controls and made for those ones who prefer to lead their projects in them.
And we cannot emphasize enough, that qmsWrapper is more than just software for QMS maintenance because it gives you an opportunity to create your own modules according to your needs. As many modules you want, on the way you want it. Even it might look outdated, it follows the most up to date management systems and having robust document management by the standard.
Plus, we do support integration with Jira. If you need any further help we are here to your assistance.

Don't hesitate to get in touch with us by email at [email protected]

Bryan B.
Overall rating
  • Industry: Information Technology & Services
  • Company size: 11-50 Employees
  • Used Weekly for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 7.0 /10

Excellent Intuitive software

Reviewed on 2020/12/30

Good experience

Good experience

Pros

Ease of use, not complicated, good overview of projects and tasks

Cons

Perhaps integration and maintenance of the Technical file, would also be useful if ISO14971 aspects would be integrated.

Response from qmsWrapper

Hi, Bryan,
We really appreciate your feedback. Regarding the ISO 14971 aspects integration, qmsWrapper has an integrated Risk Management Module, that is built based on ISO 14971 guidance and it's combined with a flexible system where you can create your own Risk processes, including approval workflows, and define risk varieties and action plans. qmsWrapper also lets you build a Traceability Matrix for all your medical device regulatory needs. It is the cornerstone of the DHF or CE Technical File. It supports linked documents in storage and allows you to use qmsWrapper's customizable forms to create custom verification and validation testing documents that will link, track, and show the connections between each. Also, you can include the reference to each identified hazard in the Risk Management Module, and directly link them in your Technical File matrix.
Please, get in touch if you have more questions regards this matter. We are happy to help.
Greetings from qmsWrapper team.

Karen M.
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 7.0 /10

QA

Reviewed on 2020/12/14

I admit, at the beginning, I was a bit reluctant when it came to using it, since we previously...

I admit, at the beginning, I was a bit reluctant when it came to using it, since we previously used
paper-based system. But, slowly, I got to a point where I was proud of myself for managing my work
through it.

Pros

For my job it is quite important to keep track of all documentation, including regulatory
submissions. In the Storage you can see all the information on one particular document – who created, number of revisions, changes through revisions, who was the author of revision, when it was reviewed, when and which revision is approved, even the comments why the revision was declined. It takes a lot
less time for showing the auditors what we did.

Cons

It was a bit time consuming setting the system, and to understand what is the best way to organize our work.

Showing 5 reviews of 12 Read all reviews

qmsWrapper FAQs

Below are some frequently asked questions for qmsWrapper.

qmsWrapper offers the following pricing plans:

  • Starting from:
  • Pricing model: Subscription
  • Free Trial: Available

The basic package includes: Team License includes: 25 Team Users + 1GB storage.

We do not have any information about qmsWrapper features

qmsWrapper has the following typical customers:

Self Employed, 2-10, 11-50, 51-200, 201-500

qmsWrapper supports the following languages:

English

qmsWrapper supports the following devices:

qmsWrapper integrates with the following applications:

Jira

qmsWrapper offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base, Chat

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