qmsWrapper

RATING:

4.6

(15)

About qmsWrapper

qmsWrapper is a cloud-based project management suite for small and midsize businesses in industries such as health care, manufacturing, education, technology and pharmaceuticals. It offers integrated tools for project, document and risk management, with an emphasis on compliance and quality management. qmsWrapper integrates quality and project management into a single workflow to assist with project oversight. Items in the project management module are mirrored in the document and quality management modules. A workflow process editor allows users to design customized workflows for specific projects. Users can organize projects and break them down into sub-projects. Staff can be organized into workgroups and assigned different roles for different projects. Task...

qmsWrapper Pricing

Our subscription is annual. Pricing varies based on user count and QMS software type (medical device or ISO 9001). *Additional GBs cost $18/year and can be added anytime. Contact us for details.

Starting price: 

$1,920.00 per year

Free trial: 

Not Available

Free version: 

Not Available

Process Framework
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qmsWrapper Reviews

Overall Rating

4.6

Ratings Breakdown

Secondary Ratings

Ease-of-use

4

Customer Support

5

Value for money

4.5

Functionality

4

Most Helpful Reviews for qmsWrapper

1 - 5 of 14 Reviews

Jonathan

Medical Devices, 2-10 employees

Used daily for less than 6 months

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

4

FUNCTIONALITY

4

Reviewed September 2017

Very happy to have found, even happier to recommend!

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.

Paddy

Medical Devices, 2-10 employees

Used weekly for less than 12 months

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

5

EASE OF USE

4

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

Reviewed May 2021

A complete beginner ...

Coming from ground zero I think there needs to be more to help in getting started and in understanding the fundamental approach of qmsWrapper. Having said that, for someone with a little knowledge of quality management systems it may be much more intuitive. I am impressed with the level of integration and system stability, and apart from the odd minor change to programs from that which is documented in the Help Guide, I have not been able to break it yet.

PROS

As part of a very small startup medical device development company I was given the task of looking at compliance. While familiar with IT systems in general, I had zero QMS knowledge and experience, and indeed still coming to terms with the concepts and practice. At the start it would have been very helpful to have video tutorials and / or an overview diagram as to how the system works, but in their absence I ended up printing out the user manual and working my way through that and setting up a demo project to play with. I did come across a few bugs, but these were acknowledged when reported and hopefully addressed. When stumped, I had quick replies to any queries which was appreciated. From a purely IT perspective the level of integration and process / document control is impressive.

CONS

I have started working on the quality manual "add-on", and while appreciating the approach being taken to use a template document integrated to the core product to permit an automated GAP report, the very limited word processing functionality in the design and amendment of the manual is for me a major issue, particularly as I am of an age where grammar matters and a document's look and feel is important.

Reason for choosing qmsWrapper

Good price and look and feel.

Metehan

Medical Devices, 51-200 employees

Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

OVERALL RATING:

1

EASE OF USE

2

VALUE FOR MONEY

2

CUSTOMER SUPPORT

5

FUNCTIONALITY

1

Reviewed December 2020

Outdated Software

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

Vendor Response

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 contact@qmswrapper.com

Replied December 2020

Karen

Medical Devices, 11-50 employees

Used daily for more than 2 years

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

5

EASE OF USE

3

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

3

Reviewed December 2020

QA

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.

Reason for choosing qmsWrapper

The qmsWrapper is selected based on the possibility to create your own modules for recording (not just quality) events.

Bill

Medical Devices, 51-200 employees

Used daily for less than 12 months

Review Source: Capterra
This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

OVERALL RATING:

5

EASE OF USE

4

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed December 2020

Very pleased with the software.

PROS

Document management is crucial for my department. But I have to mention, that we are using qmsWrapper not only for QMS, which pleased very much our needs. eSignatures for document approval is something that made us definitely say yes to the software, besides all other features and their price. They may even be a little unrealistically cheap, but if it suits them that way, it suits us as well.

CONS

In the very beginning, we struggled a bit with its use, but with their 'how-to' documentation, and all other instruction, and wonderful customer support, it became a tool it's hard to live without. Some of our employees said it's not intuitive enough, but I would say it's not on the first ball.