qmsWrapper Software

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.

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.

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.

Advice to Others

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.