qmsWrapper

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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

Vorteile

Easy to understand, Helpful team, Quick response and availability

Nachteile

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

Vorteile

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.

Nachteile

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.

Vorteile

Implementing the design controls and risk management activities is intuitive. qmsWrapper's Traceability Matrix helps us to develop device and to have Technical File with one click. When you have support like theirs, you don't have to worry about how your employees would accept working in software.

Nachteile

When they have an upgrade, I often come across a bug that they fix in a few days. It really suits our needs and I can't single out bigger cons.

Vorteile

Easy QMS implementation with qmsWrapper. Free process templates (editable) to use. We also create a new (our own) processes, and issues to collect some data. We are managing all projects from our company in qmsWrapper.Support is great.

Nachteile

Slow system sometimes, but that is not a big problem to our company.

Vorteile

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.

Nachteile

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.

In Betracht gezogene Alternativen

Vorteile

I really like the newest version of the software as it allows me and my team to go through the six modules easily. Definitely we can organize better, trace efficiently and manage all our documentation and more.

Nachteile

I don´t have any complaints by far about the software. I think is the opposite, it allowed us to have a high quality software that allowed us to get through our FDA submission easily and more efficient than any other software we have used before.

Vorteile

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

Nachteile

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

Vorteile

I love that they have a good Tractability Matrix that helps our company a lot. Every document is on right place and no more loosing files and problems when it goes to approve.
Also, the support team is very kind and always helping when we need some questions.

Nachteile

We are using this software many years and I don't have any objection about it.

Vorteile

The offering is less expensive compared to other similar software.

Nachteile

When I did the trial the software was not comprehensive of all QMS functions.

Vorteile

Easy to use, with a great could based storage features. This helps a lot to keep our regulatory on point.

Nachteile

It would be nice to have more initial storage for the basic

Vorteile

easy to use and intuitive feature of the software

Nachteile

nothing specific that I can say as a negative feature

Vorteile

Lots of tools and features and overall easy to use.

Nachteile

Automatic linking of documents when you make updates.