qmsWrapper Pricing, Features, Reviews & Comparison of Alternatives

qmsWrapper

QMS software for Medical Device startups

5.0/5 (3 reviews)

qmsWrapper overview

What is qmsWrapper?

It's everything you'll need for your FDA and CE mark submission.

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

QMS PROCESSES + PROCESS EDITOR
• Drive out mistakes, and automatically track compliance needs and issues through projects
• Modify, edit or create new QMS Processes to meet your own particular needs.

TRACEABILITY MATRIX, FDA 510K & CE MARK
Track, manage and organize all your CE Technical Files and FDA Device History Files in a fully integrated Traceability Matrix.

RISK MANAGEMENT, ISO 14971
Identify, evaluate and mitigate risks through the single matrix interface! With complete risk assessment, effective throughout your product’s entire lifecycle.

DOCUMENT MANAGEMENT & VERSION CONTROL & SOPs, DHFs
Robust, comprehensive and automated Document Management for anybody who really hates paperwork!

TEAM MESSAGING
Secure, internal team messaging.

Role-Based permissions + Flexible workgroups and customizable roles for each project.

ELECTRONIC SIGNATURES, FDA QSR 21 PART 11

21st CENTURY QMS, WORKS “RIGHT-OUT-OF-THE-BOX”
Whether an accidental Quality Manager or a seasoned professional easily step into the role and effectively organize a productive compliance savvy team. Get started in 10 minutes!

INTEGRATED, ALL-IN-ONE
Don’t use separate software apps for handling projects, QMS, and team communication. Save money, eliminate compatibility issues and keep the focus by not having to switch between apps.

VALIDATION FOR USE DOCUMENTATION SET

Optional Add-on:
QUALITY MANUAL + GAP REPORT

Pricing:
25 Users + 1GB Storage
$995,00 per year
Additional Storage possible up to 500GB.
1GB per $18,00.
www.qmswrapper.com

Pricing

Starting from
$995/year
Pricing options
Value for money
View Pricing Plans

Devices

Business size

S
M
L

Markets

United States, Asia, Canada, Europe

Supported languages

English
qmsWrapper screenshot: Process FrameworkFrankenstina software vs qmsWrapperqmsWrapper screenshot: Create TaskqmsWrapper screenshot: ProcessqmsWrapper screenshot: QualityManualqmsWrapper screenshot: Risk ManagementqmsWrapper screenshot: Traceability MatrixThe qmsWrapper Quality System Manual Creator & GAP Report Tool

qmsWrapper reviews

Excellent
3

Very good
0
Average
0
Poor
0
Terrible
0
Value for money
Features
Ease of use
Customer support
  5.0
  4.3
  4.7
  4.7
Emma Fortin

Recommend this software

Used daily for 2+ years
Reviewed 2019-07-26
Review Source: Capterra

Pros
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.

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

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 10/10

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Jonathan El-Sharkawy

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

Minimize review

qmsWrapper pricing

Starting from
$995/year
Pricing options
Free trial
Subscription
View Pricing Plans

$995 per Year
Team License includes: 25 Team Users + 1GB storage.

qmsWrapper features

Activity Dashboard
Activity Tracking
Audit Trail
Auditing
Automatic Notifications
Compliance Management
Customizable Reporting
Data Import/Export
Document Management
Document Storage
Real Time Reporting
Reporting & Statistics
Third Party Integration
Workflow Management

API (607 other apps)
Billing & Invoicing (262 other apps)
Inventory Management (364 other apps)
Inventory Tracking (299 other apps)
Monitoring (267 other apps)
Real Time Data (322 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

• Easy to follow up already running processes in Jira.

• Traceability Matrix is your dashboard for jor FDA and CE Mark submission.

• Better efficiency when multiple users are working at the same time in Traceability Matrix.

• Collecting data is straightforward with forms.

• 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.

• ISO 14971 based flexible Risk Management, create your own Risk processes, define your own risk varieties, action plans and deal with Risk Analysis with no pain.

• 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”.