# qmsWrapper Reviews **Vendor:** qmsWrapper **Category:** [Quality Management Systems (QMS)](https://www.g2.com/categories/quality-management-qms) **Average Rating:** 4.5/5.0 **Total Reviews:** 61 ## About qmsWrapper VALIDATED Medical QMS System purpose built to facilitate compliance with standards ISO 13485, ISO 14971, 21 CFR part 11, ISO 9001 and regulations enacted by the FDA. Very complete including: Document-, Project-, Quality-, Risk-, Training-, CAPA-, Change-,Complaint-, Supplier-, Audit-, Nonconformity Module; Traceability Matrix for DHFs, inbuilt Team Messaging, Processes, Procedure Templates, Quality Manual, Forms, many more, Jira integration. Reliable+Secure+Flexible+Affordable even for startups. Our pricing is for annual subscription. Starter 10 Package starting from $500/month/10 users +1GB, providing access to ALL MODULES and services for ALL USERS from Day 1, as well as lifetime in-house support. We offer eight additional packages based on the number of users. qmsWraper cloud-based QMS using the latest technology and powerful feature set has transformed the quality management systems of 800+ Companies into a collaborative and paperless environment for continual improvement. Book Your Live Demo: contact@qmswrapper.com ## qmsWrapper Pros & Cons **What users like:** - Users value the **ease of use** and flexibility of qmsWrapper, facilitating quick implementation and support. (4 reviews) - Users value the **flexibility and feature-richness** of qmsWrapper, facilitating effective data management and integration. (4 reviews) - Users value the **exceptional customer support** of qmsWrapper, highlighting quick responses and helpful assistance throughout their journey. (3 reviews) - Users appreciate the **customization capabilities** of QMS Wrapper, allowing for tailored workflows and forms to meet diverse needs. (2 reviews) - Users value the **flexibility** of qmsWrapper, adapting seamlessly to evolving compliance standards and workflows. (2 reviews) - Users value the **seamless integrations** of qmsWrapper, particularly its compatibility with Jira for streamlined project management. (2 reviews) - Intuitive (2 reviews) - Reporting (2 reviews) - Scalability (2 reviews) - Audit Management (1 reviews) **What users dislike:** - Users face **feature limitations** with qmsWrapper, especially regarding electronic signatures and online file modifications. (2 reviews) - Users struggle with **document retrieval** in qmsWrapper, as tags do not effectively aid in finding files. (1 reviews) - Users struggle with **inefficient searching** , making it difficult to locate documents despite the use of tags. (1 reviews) - Users note that the **limited customization** options in qmsWrapper hinder tailored solutions for their specific needs. (1 reviews) - Users express concerns over **limited flexibility** , particularly regarding access control and online file modifications. (1 reviews) - Limited Reporting (1 reviews) - Time Consumption (1 reviews) - Time-Consumption (1 reviews) - Visibility Issues (1 reviews) ## qmsWrapper Reviews ### 1. qmsWrapper is an excellent choice for a company looking into enhancing their internal QMS. **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** December 21, 2021 **What do you like best about qmsWrapper?** Attractive price. The software is validated. Has default procedures relevant to most Quality Management Systems. **What do you dislike about qmsWrapper?** I would like it if the software templates were slightly more customizable. **Recommendations to others considering qmsWrapper:** If you're looking for an upgrade from a paper-based system for a cost-effective price and want an eQMS with full ISO 13485 compatibility, qmsWrapper is a solid choice. **What problems is qmsWrapper solving and how is that benefiting you?** We have some internal procedures which require our systems to be set up a certain way. So we had to work around these things listed in the guidelines since qmsWrapper forms aren't customizable. Benefits of the software include a fully comprehensible eQMS where before implementation, everything was paper-based. Using qmsWrapper has made things easier on the QMS. ### 2. Excellent eQMS for Medtech Start-up! **Rating:** 4.5/5.0 stars **Reviewed by:** Andrew F. | Chief Product Officer, Small-Business (50 or fewer emp.) **Reviewed Date:** January 25, 2021 **What do you like best about qmsWrapper?** This is an affordable way to get started into an eQMS system. We were able to use it as a good document control system and then build out the other parts of the QMS as we needed them and when we had the time and resources to get at them. We need to be concerned about ISO 13485 standards, risk and traceability and qmsWrapper has the elements that we need. We also like the Jira implementation although we're just starting to work on this aspect. **What do you dislike about qmsWrapper?** The product is relatively new and continuously improving ... but it means sometimes there are some bugs or slowdowns. Tech support has been fantastic when we have had issues. Also, it would be great to have even more tutorials and an online community of support but these will no doubt continue to grow. **Recommendations to others considering qmsWrapper:** This is a great value for the price and meets all of our requirements as a small medtech start-up. **What problems is qmsWrapper solving and how is that benefiting you?** We are meeting all of our regulatory requirements without having to radically change the way that we work to fit within some larger software system. qmsWrapper allows us to focus on product development/improvement and clients instead of on our quality system. ### 3. Good eQMS for startups **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** March 31, 2021 **What do you like best about qmsWrapper?** The most used feature is document management. The software provides an easy way to organize the files and how we are dealing with the documents and records in general. This has been appreciated as we had our external audit in the pandemic. The QMS module is extremely helpful to keep track of the ongoing and finished processes. Lastly, the custom form is a very interesting option to record something, so we are glad that this is a possibility now. Overall, it is a good solution for small startup that is just begining to implement QMS in their system. **What do you dislike about qmsWrapper?** What we are currently missing is a notification system. For example, when someone sends a document for review/approval, you don't see it until you check the dashboard. So, a notification email would be a nice feature. **What problems is qmsWrapper solving and how is that benefiting you?** Using qmsWrapper we transferred from paper-based to an electronic system. The benefits are that all the documents at the same place, the electronic signature, easier to keep track of processes. ### 4. An easy approach for Startups **Rating:** 4.5/5.0 stars **Reviewed by:** Stephan W. | Small-Business (50 or fewer emp.) **Reviewed Date:** December 08, 2020 **What do you like best about qmsWrapper?** One of the best parts is, that you always get to the desired functions. The navigation on the left is understandable and works as expected. The document management system (DMS) is working fine and for this price level very good, especially as you can download the files easily. Also, if you look for ISO 13485 certification, it comes with a complete pre-made QM handbook! **What do you dislike about qmsWrapper?** The DMS doesn't allow for checkout. So if several people downloaded the file in parallel, they could overwrite others edits unknowingly. Also, if you look for multiple languages - not there. **What problems is qmsWrapper solving and how is that benefiting you?** To start a certification in a startup with no structure might seem like a nice place to work. But consider all the work that has to be done to setup a classic "paper-process-excel-file-system"-approach. Not that funny, right? So here comes QMS Wrapper and provides a solid basis. Get things done fast. That's the biggest benefit. ### 5. Great software for startups! **Rating:** 3.5/5.0 stars **Reviewed by:** Bojan M. | Marketing and Communications, Small-Business (50 or fewer emp.) **Reviewed Date:** May 12, 2021 **What do you like best about qmsWrapper?** I like how we can use chat feature to communicate in the real-time and I also like how we can manage the documents within the Storage. **What do you dislike about qmsWrapper?** It is not that I dislike, but I think the notification system could be more efficient. **What problems is qmsWrapper solving and how is that benefiting you?** Using qmsWrapper helps our company implement and maintain the QMS. The benefits we see is the organized approach to the QMS, using document control management as the most important part. ### 6. Great flexibility for startups **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** December 01, 2020 **What do you like best about qmsWrapper?** qmsWrapper provides the ability to organize and document activities with flexibility for our company's developing needs a price point that is significantly lower than the prohibitive pricing of most alternatives. **What do you dislike about qmsWrapper?** Some aspects of our quality system require creativity (especially employee training management) to implement in qmsWrapper. Other aspects (e.g., some forms) while helpful, do not meet all requirements for FDA purposes so cannot be fully utilized. This has resulted in some creative solutions which are still electronic and useful, but not quite as automated as hoped. **What problems is qmsWrapper solving and how is that benefiting you?** We are fully electronic in our quality management which has significantly improved efficiency, accuracy and also helpfully allowed business to continue during quarantine requirements in 2020. Auditors have been largely pleased with the system. ### 7. I would absolutely suggest to startups **Rating:** 4.0/5.0 stars **Reviewed by:** Marina V. | Mid-Market (51-1000 emp.) **Reviewed Date:** May 27, 2020 **What do you like best about qmsWrapper?** I like qmsWrappers DMS and we can manage projects easily. My favorite part is the Quality Manual - it is editable and we were able to adjust it to our company in short notice. With this tool, we saved time. Traceability Matrix helps with Design Control of the product life cycle. **What do you dislike about qmsWrapper?** In the beginning, it was a bit complicated to use qmsWrapper. When you learn how to use qmsWrapper, it can help you a lot to keep up with your projects and QMS. They offer free documentation "How to" in which you have explained how to work in the software, step by step. Also, we had problems with some bugs, but they handled it really quickly. **Recommendations to others considering qmsWrapper:** Check their pdf file: "Things to know before you buy qmsWrapper". I am suggesting to all startups and small businesses because the software is not expensive, and you can easily implement QMS and you can manage your projects. **What problems is qmsWrapper solving and how is that benefiting you?** The whole team is working together and everything is transparent (who completed the task, when, why, who approved, what is the previous version of the doc, etc.). ### 8. Affordable way to get and maintain your ISO certificate and documentation **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** May 13, 2020 **What do you like best about qmsWrapper?** I have complete documentation needed for a proper certfication and it is easy to maintain it in qmsWrapper. I am working in a small comapny with a small crew and we have multiple roles, so it is hard to follow up every process and protocol required by the standard. We were looking for an affordable but guiding software, which can lead us to a successful implementation of ISO standards. As a QMS person, my favourite part of the software are the processes with documentation management involved into one. **What do you dislike about qmsWrapper?** As every software generally, qmsWrapper also have its small issues. Sometimes it can be a long reaction time, sometimes a bug appears. Otherwise, I know when I report them, I got a fast response from the technical support crew and issues are solved fast. **What problems is qmsWrapper solving and how is that benefiting you?** Easy path to ISO certification, much easier maintain of documentation, all in one software for my complete team and the most important is, its affordable for teams with very strict budget, like ours. ### 9. New update makes easier to use **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Biotechnology | Enterprise (> 1000 emp.) **Reviewed Date:** June 09, 2020 **What do you like best about qmsWrapper?** The newest update allows us to go through the 6 modules more easily and stay better organized. **What do you dislike about qmsWrapper?** Nothing so far! this software has allowed us to get through our FDA submission efficiently. **What problems is qmsWrapper solving and how is that benefiting you?** We used to have separate training in MasterControl and project management tools in Asana, but now everything is combined. ### 10. Beyond QMS, beyond PM, and far more than a complete solution **Rating:** 5.0/5.0 stars **Reviewed by:** Jonathan E. | Product Manager, Medical Devices, Small-Business (50 or fewer emp.) **Reviewed Date:** October 03, 2017 **What do you like best about qmsWrapper?** qmsWrapper has been where we are & knows where we want to go **What do you dislike about qmsWrapper?** The lack of synchronization with your native calendar client **Recommendations to others considering qmsWrapper:** I have reviewed almost all the QMS systems out there; this, for our needs (medical device, ISO 13485 / FDA 510k) was by far the best. It is actually quite humble and its marketing does not show you all of its potential and what it can do for you; please request a demo and go through the quality manual, gap analysis, and process they then map to - use a process that comes with a template and you will see how effectively this system walks you through your regulatory requirements. Honestly, I am normally very pessimistic and after 2 decades in software I always pick holes. This system isn't perfect by any means (no mobile app, no native calendar client sync), but it's miles ahead of the others! **What problems is qmsWrapper solving and how is that benefiting you?** qmsWrapper solves all our regulatory problems, in one system, while saving us £1000's over our previous QMS system, Master Control. It builds us a quality manual based on our specific requirement, shows us what processes to implement in order to adhere to said manual, walks us through those processes using project management methodologies, and even gives us the templates we need to populate to be compliant. ### 11. A perfect all in one eQMS software for a medical device start-up company **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Computer Software | Small-Business (50 or fewer emp.) **Reviewed Date:** September 28, 2017 **What do you like best about qmsWrapper?** Project management, Quality management, cloud-based Storage and team communication module in one software. No need for 3 different ones. **What do you dislike about qmsWrapper?** It is still new on the market and needs improvement, but it is already far better then some other eQMS software and it is only going to be much better! **Recommendations to others considering qmsWrapper:** Make your ISO 13485:2016 compliance easy with qmsWrapper. It has all features you need, without using any third party software. Let the processes guide you through ISO 13485:2016 with the relevant templates included, and be a successful QMS manager even if you are still new in the territory of quality management. **What problems is qmsWrapper solving and how is that benefiting you?** It makes easy to implement QMS into a start-up company and getting ISO certification. Also, whole company and project related tasks and other issues can be followed-up both by the QMS manager and project managers. qmsWrapper is a cheap solution for small teams who needs a software for their ISO 13485:2016 compliance. ## qmsWrapper Discussions - [Is qmsWrapper validated for use?](https://www.g2.com/discussions/25971-is-qmswrapper-validated-for-use) - 2 comments, 1 upvote - [Is Technical Team support available at any time of use of the software?](https://www.g2.com/discussions/24593-is-technical-team-support-available-at-any-time-of-use-of-the-software) - 1 comment, 1 upvote - [Can you help me when an audit comes?](https://www.g2.com/discussions/24087-can-you-help-me-when-an-audit-comes) - 2 comments, 1 upvote - [Is my organization's data and information safe in the Cloud?](https://www.g2.com/discussions/24086-is-my-organization-s-data-and-information-safe-in-the-cloud) - 3 comments, 1 upvote - [How does qmsWrapper help my company achieve regulatory compliance?](https://www.g2.com/discussions/how-does-qmswrapper-help-my-company-achieve-regulatory-compliance) - 1 comment, 1 upvote - [View qmsWrapper pricing details and edition comparison](https://www.g2.com/products/qmswrapper/reviews?page=2§ion=pricing&secure%5Bexpires_at%5D=2026-05-29+15%3A17%3A12+-0500&secure%5Bsession_id%5D=4a536249-5690-4a8d-a73b-67e096a63bc1&secure%5Btoken%5D=b37c631d1de78dbea8a2166b9a7412c1d4ff14de565db07c7d63af71a88d50ec&format=llm_user) ## qmsWrapper Integrations - [Jira](https://www.g2.com/products/jira/reviews) ## qmsWrapper Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Nonconformance** - Conformance Records - CAPA - Change Management **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Quality system** - Document Control - Collaboration - Analytics and Reports **Risk Management** - Assessments - Operational Risk - Supplier Evaluation **Inspection Management** - Templates - Workflows - Corrective Actions **Compliance** - Standards & Regulations - Permits - Certifications **Platform** - Integration - Security & Privacy - Flexibility **Services** - Implementation - Training & Learning - Customer Support - Professional Services ## Top qmsWrapper Alternatives - [Greenlight Guru Quality Management System](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews) - 4.5/5.0 (401 reviews) - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (736 reviews) - [Arena PLM & QMS](https://www.g2.com/products/arena-plm-qms/reviews) - 4.2/5.0 (432 reviews)