qmsWrapper Pricing, Features, Reviews & Alternatives

qmsWrapper

QMS software for startups and small businesses

4.58/5 (12 reviews)

qmsWrapper overview

What is 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
www.qmswrapper.com

Pricing

Pricing options
Subscription
Free trial
Value for money
View Pricing Plans

Devices

Business size

S
M
L

Markets

United States, Canada

Supported languages

English
qmsWrapper screenshot: Process FrameworkProject & Quality Management SystemqmsWrapper screenshot: Create TaskqmsWrapper screenshot: ProcessqmsWrapper screenshot: QualityManualqmsWrapper screenshot: Risk ManagementqmsWrapper screenshot: Traceability Matrix

qmsWrapper user reviews

Value for money
Features
Ease of use
Customer support
  4.4
  4.1
  4.1
  4.7
Jonathan E.

Very happy to have found, even happier to recommend!

Used daily for less than 6 months
Reviewed 2017-09-06
Review Source: Capterra

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.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 10/10

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Metehan A.

Outdated Software

Used monthly for free trial
Reviewed 2020-12-09
Review Source: Capterra

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 contact@qmswrapper.com

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 0/10

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Bryan B.

Excellent Intuitive software

Used weekly for less than 6 months
Reviewed 2020-12-30
Review Source: Capterra

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.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 7/10

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Karen M.

QA

Used daily for 2+ years
Reviewed 2020-12-14
Review Source: Capterra

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.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 7/10

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Bill M.

Very pleased with the software.

Used daily for 6-12 months
Reviewed 2020-12-09
Review Source: Capterra

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.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 9/10

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qmsWrapper pricing

Pricing options
Subscription
Free trial
View Pricing Plans

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

qmsWrapper features

Access Controls/Permissions
Activity Dashboard
Alerts/Notifications
Audit Management
Audit Trail
Compliance Management
Customizable Reports
Data Import/Export
Document Management
Reporting & Statistics
Search/Filter
Status Tracking
Third Party Integrations
Workflow Management

API (852 other apps)
Billing & Invoicing (554 other apps)
Inventory Management (825 other apps)
Mobile Access (737 other apps)
Reporting/Analytics (1026 other apps)
Work Order Management (524 other apps)

Security and privacy

Encryption

Encryption of sensitive data at rest
HTTPS for all pages

Access control

Multi-factor authentication options
This will ask you to sign in with LinkedIn

Videos and tutorials

Additional information for qmsWrapper

Key features of qmsWrapper

  • Action plans, analysis, charts, risk reports
  • Activity dashboard
  • Audit management
  • Central Repository
  • Commenting
  • Complete Validation For Use Documentation set
  • Corrective actions (CAPA)
  • Create and schedule QMS meetings by task, topic or project
  • Create milestones, versioning, approval workflows
  • Customizable roles for projects
  • Document approval workflows
  • Document management and Control
  • Drag and drop upload
  • Electronic Signature
  • Flexible workgroups
  • Follow-ups, statistics and investigation
  • Gantt calendar view
  • ISO standards management
  • Identify threats
  • Insert triggers and reporting points to QMS processes
  • Manage, assign & track team progress
  • Multi User Traceability Matrix
  • Project management
  • QMS Processes, Workflow Processes and Process editor
  • Quality Manual Builder Tool
  • Quality management
  • Quality management meetings
  • Risk identification & management
  • Sync with storage
  • Team collaboration and management
  • Track issues to product releases
  • Tracking the recurrence of issues
  • Unlimited projects, subprojects, tasks, issues
View All Features

Benefits

• 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.