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qmsWrapper

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61 reviews
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4.5
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qmsWrapper Reviews

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Lise V.
LV
Lise V.
Quality Manager at Tata Consultancy Services
05/21/2025
Validated Reviewer
Verified Current User
Review source: Organic

Better than the others we used so far

We purchased a license in 2019, now is 2025 and still sticking with QMS Wrapper. It's been 6 years with this software, so this review will be long! The software continues to evolve with the changing regulatory environment, yearly introducing new features, yet the pricing for long-time customers has remained unchanged, since 2019! I really appreciate the priority support, the loyalty and respect we receive from the QMS Wrapper team. The onboarding was efficient, implementation and integration went smooth, but the continuous support is what we appreciate the most, our account representative, Timea answers on our questions within an hour. We had features requests- they were all implemented. In the beginning we only needed ISO13485 and 14971, but as our organization expanded, we needed to comply with additional standards: QMS Wrapper system proved to be flexible enough, we simply created our own workflows and forms, and the system was fully capable of supporting any new standard we added, easily added them into the CAPA module, Deviation, Training, or Risk Management. Through my 20+ years in the regulatory industry, I’ve worked with several QMS software solutions, enough to make meaningful comparisons. Small software often lacks the features needed, while large systems tend to be overly heavy, slow and complex; QMS Wrapper is comprehensive yet lightweight, easy to navigate with a modern interface. And I know that this review sounds like a paid post, but it is not, I never wrote a review for the past 6 years. I’m glad we found QMS Wrapper, and I’m more than happy to recommend it!
Sonja  A.
SA
Sonja A.
09/19/2024
Validated Reviewer
Review source: Organic

Great Report Feature

The Report feature is very useful in combination with the Custom form. I like that most of the features can be adjusted according to the needs of the company. Although it is easy to use, the trainings helped our team for quicker implementation, so I must say that Robert and other people from the support team were very helpful.
Gertruda H.
GH
Gertruda H.
09/16/2024
Validated Reviewer
Review source: Organic

Overall Ok

Easy onboarding, nice support team that works in qmsWrapper, and very helpful. It is comprehensive in terms of features, modules, and functionality, however, this can sometimes be a disadvantage if you do not need all the features. It is particularly notable for its flexibility and the possibility of logging in, regardless of whether you work from home or the office. Excellent ability to integrate with Jira.

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Toronto, Ontario

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What is qmsWrapper?

qmsWrapper is a comprehensive quality management software designed specifically for medical device manufacturers and companies regulated by the FDA. The platform aims to streamline and enhance the effectiveness of quality management systems (QMS) by integrating project management, document control, risk management, and ISO 13485 compliance processes within a single framework. qmsWrapper's user-friendly interface and modular design make it adaptable to the needs of businesses of various sizes, from startups to established enterprises. With features like traceability, collaboration tools, and built-in compliance pathways, qmsWrapper helps organizations manage their quality processes more efficiently, ensuring compliance with relevant regulations while supporting the goal of delivering safe and effective medical devices to market.

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