I like that qmsWrapper is not afraid of using AI in its modules. It is a solid QMS platform with more than 16 modules that work together seamlessly, with a lot of automation. The newest release added multiple layers of AI that are not just automating execution but also help with brainstorming, give suggestions, and maintain the technical file, etc. That is a whole new level that was previously unseen.

I have been in the industry for over 15 years. I started with paper-based QMS systems, then migrated to electronic QMS silos that were still very manual work. After that came automation with automated workflows and task execution, and now AI.

The difference between how QMS-related activities were handled 15 years ago and today is huge. I can't even explain it to the younger people who never saw a scanner and never used a pen to sign a document. Review collected by and hosted on G2.com.

Every system is only as good as how much the team actually uses it. There is a learning curve with any QMS system. The most painful transition is usually from a paper-based system to an electronic one, but that is not because of the system.. it’s because of human habits. Review collected by and hosted on G2.com.

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! Review collected by and hosted on G2.com.

During these 6 years I had multiple pain points, believe me, such as electronic signatures physically on documents, being able to modify files online, I wanted to see separate logs for our CAPAs, NC and Hazards; I wanted to see flexible access control for not just document control but also for tasks, filled forms, etc. ...these are all solved, the technical team evaluates the feature requests and implements them in at a timely manner. Review collected by and hosted on G2.com.

The most helpful feature is the event capture option. Every time we get a data point, the app makes it easy to capture it and assign it to someone so it can be dealt with properly. Review collected by and hosted on G2.com.

As a Spanish speaking individual, I would feel more comfortable having the app in Spanish. Review collected by and hosted on G2.com.

The app is specifically designed with MedTech in mind. There are built in workflows, document control and compliance tools that are aligned with ISO13485 and FDA. I dont have to spend half my day chasing some missed files or worry about the file not being up to date Review collected by and hosted on G2.com.

I would like to have some AI integration. That would speed up our work even more Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

As I already mentioned, too many functions and features can be a disadvantage for some companies. In addition, creating a process can take a lot of time, so it would be good to provide additional services for companies that do not want to waste time on it. Review collected by and hosted on G2.com.

The application is easy to navigate. It is useful to have easy access to files all in one place, and live monitoring on the status of documents. Email notifications when something needs approval are also helpful. Review collected by and hosted on G2.com.

It would be helpful if the application would generate document numbers and keep a document master index within the application. It is inconvenient managing document master index outside of the application. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

It is hard to find some documents, tags are not helping. Review collected by and hosted on G2.com.

Help desk team has been super helpful, and the training made it much easier for my team to understand how to use the tool. It took about two weeks for us to implement, and now I’m using most of the features available in qmsWrapper. Review collected by and hosted on G2.com.

The software can be a bit slow at times, particularly after a new update is released. Review collected by and hosted on G2.com.

The system is automated, easy to use, processes are prepared quickly (prepared processes are a big help), risk assessment is covered in detail in the module. All recommendations. The help desk team (especially Timea) is great, training classes are free. Review collected by and hosted on G2.com.

It may be too complicated for companies that don't need all the functionality. Review collected by and hosted on G2.com.

All features are included in the price, easy implementation, and integration with Jira. Everything that is needed for managing QMS is on one place + we handle all company projects in qmsWrapper. Review collected by and hosted on G2.com.

qmsWrapper does not offer consulting services, but you can schedule trainings to help you with the software. Review collected by and hosted on G2.com.