# Qualcy QMS Reviews 2026. Verified Reviews, Pros & Cons | Capterra

> Is Qualcy QMS the right Quality Management solution for you? Explore 21 verified user reviews from people in industries like yours to make a confident choice.

Source: https://www.capterra.com/p/164198/Document-Management-System/reviews

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Qualcy QMS

5 (21)

[View alternatives](https://www.capterra.com/p/164198/Document-Management-System/alternatives/)

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Last updated March 13th, 2026

# Reviews of Qualcy QMS

Ease of use

4.7

Customer Service

4.9

## Pros and Cons in Reviews

TG

Tamala G

acting Quality Assurance Manager-Operations ManagerMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months.

“It is intuitive, well-structured, and keeps every component of the CAPA together—task assignments, root cause analysis, and effectiveness review are all in one cohesive place.“

November 24, 2025

TG

Tamala G

acting Quality Assurance Manager-Operations ManagerMedical Devices, 2 - 10 employeesUsed the software for: 6-12 months.

“The integration between document revisions and training assignments is also excellent, making it incredibly straightforward to keep our training program aligned and compliant.“

November 24, 2025

JB

Josh B

PresidentBiotechnology, 2 - 10 employeesUsed the software for: Less than 6 months.

“The workflow management is intuitive and efficient, accompanied by robust document management functionalities.“

September 21, 2023

SC

Samuel C

Chief Operating OfficerTransportation/Trucking/Railroad, 11 - 50 employeesUsed the software for: 6-12 months.

“One of the standout aspects of Qualcy QMS is its superior customer support.“

August 22, 2023

## Showing most helpful reviews

Showing 1-21 of 21 Reviews

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Frequency of Use

TG

Tamala G.  
acting Quality Assurance Manager-Operations Manager  
Medical Devices  
Used the software for: 6-12 months

### "Qualcy means Quality"

November 24, 2025

5.0

The Qualcy team delivers exceptional customer support. Their responsiveness, thoroughness, and genuine patience set them apart. Every time I’ve encountered a challenge or had a question, I’ve felt completely supported—with prompt replies, clear guidance, and the option of Zoom meetings that make problem-solving smooth and stress-free. Sanjay, in particular, has been invaluable; his expertise and willingness to help have consistently gotten me back on track quickly and confidently. Although I had previous experience with TrackWise, that familiarity did not translate to Qualcy at first. However, as I’ve grown more comfortable with the system, it has become clear just how thoughtfully designed it is. As someone leading implementation of a compliant QMS in a small business, the Training, CAPA, and Document Management modules have been especially impactful. The document control functionality has exceeded our expectations. One feature I truly appreciate is how intelligently Qualcy handles revisions—keeping the current approved version fully accessible while a CCR is in progress. Many systems lock documents during edits, but Qualcy’s approach allows work to continue seamlessly and avoids unnecessary workflow interruptions. The user-friendly Inbox is another standout. Being able to see all assigned tasks immediately upon login brings clarity and efficiency to each workday. The integration between document revisions and training assignments is also excellent, making it incredibly straightforward to keep our training program aligned and compliant. Finally, the flexibility to create templates in Excel and upload them directly into the system has been a huge advantage. Once I understood the formatting requirements, the process was easy, and the resulting forms look clean, polished, and professional. Overall, Qualcy has been a powerful and supportive tool for building our QMS, and the combination of functionality, flexibility, and exceptional customer service has made the implementation process far smoother than expected.

Pros

The CAPA workflow, in particular, has been a pleasure to use. It is intuitive, well-structured, and keeps every component of the CAPA together—task assignments, root cause analysis, and effectiveness review are all in one cohesive place. This streamlined design eliminates fragmentation and enhances both clarity and traceability.

Cons

Looking forward, one enhancement that would elevate the experience even further would be the ability to create folders within the Draft and Release cabinets. The search function works well, but folder structure would make navigation even more intuitive for users managing larger document libraries.

Review Source

BS

Brian S.  
Consultant  
Medical Devices  
Used the software for: 1-2 years

### "Qualcy is a good choice"

June 5, 2025

5.0

The service is fantastic. Our POC is very responsive, knowledgeable and patient. Their attention to detail and effective training make our eQMS efforts both enjoyable and successful.

Pros

We really like the ability to do traceability between requirements docs within the eQMS. And the system is very comprehensive.

Cons

In many environments, the day to day reality of "doing quality" can be challenging. It's more of a behind the scenes function, unlike more "glossy" departments like sales, engineering or executive management. Having integration with traceability forces the quality function to interact with engineering functions more frequently, which is good for efficiency, but some engineering personalities can be challenging.

Alternatives considered

[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/)

Reason for choosing Qualcy QMS

Price and requirements traceability withing the eQMS

Review Source

CS

Carl S.  
Dir. of Quality and Regulatory  
Medical Devices  
Used the software for: 6-12 months

### "Qualcy eQMS"

November 4, 2022

4.0

The software was easy to set up, easy to use, and the support is readily available when needed. We are working through a few issues, but no deal breakers and I would recommend this software to other medical device companies as long as the risk management is updated for compliance.

Pros

Document Control is easy to implement and easy to use. Very intuitive with a Draft Cabinet, Release Cabinet, Change Control etc.

Cons

We are working on the Risk Management to comply with 14971. Also templates took a little longer to learn and implement for requirements. More templates also need to be added for forms.

Review Source

Response from Qualcy Systems

January 16, 2023

Hello Carl, Thanks for your feedback. We have been working on continuously improving our solutions for compliance with latest changes in the regulations and standards. We have implemented the changes in the recent release (Q4.2022) to comply with ISO14971:2019. Hope that has resolved the issues and enabled the compliance requirements.

HK

Hari K.  
IT Manager  
Pharmaceuticals  
Used the software for: 2+ years

### "Great QMS System for a fair price"

February 5, 2026

5.0

Overall, the experience with Qualcy QMS has been positive, particularly in environments requiring structured quality management and regulatory compliance. The platform provides a centralized system for managing quality processes, documentation, and asset lifecycle activities, which improves traceability, audit readiness, and process consistency.

Pros

Qualcy QMS provides a centralized, compliant platform for managing quality and operational processes including asset management, CAPA, document control, training, audits, and change management.

Cons

Workflow setup requires planning.Template formatting rules need to be learned.Needs structured rollout.

Review Source

Response from Qualcy Systems

February 12, 2026

Thank you, Hari! We really appreciate you taking the time to share your experience after 2+ years with Qualcy QMS. Your point about the centralized platform improving traceability and audit readiness is exactly what we're focused on making Qualcy eQMS work as strategic enablers for bio pharma companies, not just compliance checkboxes. You're absolutely right about the workflow setup and template formatting requiring planning. We've heard this feedback from several pharmaceutical customers, and we're actively working on this. The structured rollout you mentioned is actually by design for regulated environments (it ensures validation and compliance from day one), but we recognize we can make that process more intuitive. Thanks for being a fantastic long-term partner and for the 10/10 recommendation. -Qualcy Team

AA

Akshaya A.  
COO  
Health, Wellness and Fitness  
Used the software for: 1-2 years

### "Qualcy is an economical choice for quality management"

May 29, 2025

5.0

Good experience, it's an affordable option for my startup and gets the job done. Exactly what I need.

Pros

Qualcy is affordable eQMS option, has good customer service, and provides the functionality I need in an eQMS.

Cons

The user interface of the eQMS could use some updates to make it easier/more intuitive. Sometimes the server is down, but this is usually resolved in a few hours.

Alternatives considered

[Greenlight Guru Clinical](https://www.capterra.com/p/152998/SMART-TRIAL/)

Reason for choosing Qualcy QMS

We choose Qualcy QMS over other products because it was the most affordable and had traceability build in.

Review Source

KF

Kelly F.  
Laboratory Manager  
Hospital & Health Care  
Used the software for: Less than 6 months

### "Best program out there"

April 2, 2020

5.0

I am converting a completely paper based system for all internal and externals labs within my organization. This program will become a one-stop shop for all the compliance needs on these labs and will make everything effortless in creating and tracking records for all aspects of Quality.

Pros

The software is very intuitive. It is set up in the same fashion as a paper based system making the logic of the program very easy to follow.

Cons

The document management section of the software takes a long time to set up and get established. The outcome is very much worth the effort.

Alternatives considered

[Intellect Document Control](https://www.capterra.com/p/134378/Interneer-Intellect/)[MasterControl Quality Excellence](https://www.capterra.com/p/148577/MasterControl/)[QT9 QMS](https://www.capterra.com/p/97557/QT9-Quality-Management/)

Reason for choosing Qualcy QMS

The Qualcy program offered functionality for all aspects in a quality management system not just a document control feature. This program offered ease or use along with the functionality. Most Quality programs are very utilitarian and with Qualcy you get style along with the utilitarian nature of Quality management.

Review Source

Response from Qualcy Systems

September 14, 2020

Hi Kelly, Thanks for the favorable review. We are happy to know that we are able to meet your QMS and regulatory requirements.

MP

Maraea P.  
Quality Manager and IT specialist  
Hospital & Health Care  
Used the software for: 2+ years

### "Excellent product and Excellent support team"

March 31, 2022

5.0

Sanjay was a huge help in getting us setup and modifying the modules to fit our organization. It is very easy to maintain once you get all your modules set up.

Pros

Support for this product to implement and do system changes to fit our organization was amazing. Weekly zoom calls helped a lot. Made implementing and maintain the system very easy.

Cons

With Document Management would have preferred the approval process be done with this instead of having to do a CCR.

Reason for choosing Qualcy QMS

Was selected by our previous Quality Manager, mainly done because we have Numerous Labs across the country that we helped set up and had them utilizing all our SOPs

Review Source

Response from Qualcy Systems

April 4, 2022

Hi Maraea, We appreciated your feedback. We have been continuously improving our product platform to exceed the expectation of our customers. In the recent release(2022-q1) we have rolled out the direct approval of documents in additions to the previous option through CR(change request work flow). Hope this will meet your needs. Thanks Qualcy Support Team

DR

Damek R.  
Sr. QA Engineer  
Medical Devices  
Used the software for: Less than 6 months

### "high powered and customizable eQMS for a very reasonable price"

June 13, 2023

5.0

so far i am impressed with the product's value. it allows our company to move quickly without being out of control.

Pros

Qualcy has a lot of customization options to make it fit your needs. the support team is also very responsive, allowing for fast deployment of new modules within your eQMS.

Cons

there is a distinct lack of a help menu. the team can support your needs well, but there should be a way to get quick answers on basic mechanics.

Review Source

JB

Josh B.  
President  
Biotechnology  
Used the software for: Less than 6 months

### "Very Happy User"

September 21, 2023

5.0

Pros

Their team is fully compliant with 21 CFR part 11, complete with thorough audit trails and signature capabilities. The workflow management is intuitive and efficient, accompanied by robust document management functionalities. The customer support and training were outstanding, enhancing the overall positive experience.

Cons

Nothing, I am looking forward to a potential customer portal in the future, but so far everything is great!

Reason for choosing Qualcy QMS

Their consulting services were very valuable for us, the customer service and the pricing was the best value for all they offer.

Review Source

JM

Jacob M.  
Metrology Specialist.  
Biotechnology  
Used the software for: 1-2 years

### "Outstanding Quality management system "

June 5, 2023

5.0

Pros

Easy to integrate and use on day one rolling it out

Cons

Not sure there is anything that I can think of I didn’t like about it.

Review Source

MO

Mark O.  
QA Operations specialist  
Biotechnology  
Used the software for: 2+ years

### "Qualcy eQMS software"

August 12, 2020

5.0

Qualcy EQMS has been help managing the day-to-day QMS functions. Saves lot of time. Has helped us reduce the errors.

Pros

Qualcy eQMS is easy to use with intuitive pages and builtin templates. Easy to search the records from the home page of the each modules. Also export option to Excel makes it life much simpler. Handling the audits have been much easier. The closed records are always in compliance status. No more stress out to find the records or show the records during the audits.

Cons

Initial implementation took longer than what we had expected. It was worth the effort. Qualcy Support team helped us move our existing data and documents to the new system. Qualcy provided full validation report for the software, this alone saved us months of efforts.

Review Source

HK

Hari K.  
Director of IT  
Pharmaceuticals  
Used the software for: 2+ years

### "QMS Review"

June 15, 2021

5.0

Qualcy eQMS modules are easy to use and intuitive in terms of the workflows and accessibility for the documents and records. The options for electronic signatures and advanced reminders have helped a lot. Overall, it has made our lives easier.

Pros

Qualcy eQMS is a cloud based solution with pick and choose options from multiple modules. The software provides lot more value than we could have developed inhouse solution. The software includes lot of flexibility and configuration options, that we used to customize the solution to meet our requirements. The software was provided to us with full validation reports out of the box. The support team has accepted and rolled out many of our suggestions for improvements.

Cons

Overall, it has made our lives easier, it took little longer than expected to get started with system. It took us some time to understand the role permissions and access controls for the users.

Review Source

Response from Qualcy Systems

February 18, 2022

Hello Hari, Thanks for sharing your experience with Qualcy eQMS software. Looking forward to working with your team for years to come.

JB

Jeffrey B.  
Quality and Compliance Manager  
Biotechnology  
Used the software for: 2+ years

### "Robust Part 11 compliance "

August 27, 2018

5.0

Robust compliance features for part11 compliance. Easy to use. Very good technical support.

Pros

The built-in E-Signature and Part11 compliance are very strong. Very easy to access the audit trails and change histories. This Qualcy CAL/PM Software is user friendly. The navigation is simple and intuitive. The technical support is top notch with strong knowledge base in Bio-Pharma areas. They provided the complete validation package that including IQ, OQ reports. The Qualcy support team helped us complete our PQ requirements, and helped us migrate the legacy data into the new application.

Cons

Initially the application set-ups and user registrations were challenging. It took us some time to learn the administrative features. The customer support was always available, ready to help.

Review Source

AH

Antony H.  
Quality Manager  
Pharmaceuticals  
Used the software for: 1-2 years

### "Calibration PM software that best meets ours needs"

August 15, 2018

5.0

Overall smooth on-boarding and transition. Training was very effective and helpful.

Pros

The Qualcy software is flexible and configurable. The supplier of this software provided IQ, OQ validation reports which saved us a lot of time. The software complies with 21 CFR Part11 requirements. It has been very helpful for audits and compliance requirements. The software also provides option for managing PM and OOT records. This makes it easy to manage our equipment and our audit needs. Overall, satisfied with the product and account manager's support.

Cons

It was somewhat expensive compared to other products we looked at. After using the software for over a year, I think the software has paid back it's worth.

Review Source

JL

Jennifer L.  
Quality Systems Manager  
Biotechnology  
Used the software for: 6-12 months

### "Great Software and Support"

February 10, 2022

5.0

Pros

Qualcy provides a great platform for our start up company to build our Quality System in a step by step, easy to use format. The support for implementation was timely and thorough.

Cons

None.

Review Source

Response from Qualcy Systems

February 18, 2022

Hi Jennifer, Thanks for the feedback. It has been a nice experience working with you and your team.

SH

Samuel H.  
Director, QA and Compliance  
Medical Devices  
Used the software for: 2+ years

### "Flexible and user friendly"

August 22, 2018

5.0

Overall very satisfied. It is a good program.

Pros

The Qualcy CAL/PM application is highly flexible. It was easy for us to change the labels, which made the user happy, as they could use the same wordings and terminologies for internal communications. Also, the application provides option for adding additional Approvers to the records on as needed besides the minimum required approval. Also provides attachment options to attach the external certificates and documents. The workflow is simple and easy. Very nice documentation for compliance purpose.

Cons

Expensive compared to other options we looked at. The cost included validation package, training support and data migration. I think it is well worth it.

Review Source

Response from Qualcy Systems

August 26, 2018

Thanks for the positive feedback.

MB

Margie B.  
Sr. Quality Manager  
  
Used the software for: 2+ years

### "Very helpful, simple and easy to use"

June 13, 2018

5.0

Pros

We had lot of existing equipment data that was migrated using an Excel upload option. It was very helpful. No manual data entry was required. It saved us lot of headache. This system is simple and easy to use. It is very easy to find the information when needed. It has been very helpful to manage the CAL, PM, OOT records for equipments that we use in the labs and manufacturing area. The reporting functionality provides quick view of the metrics for coming due records and overdue records. The reminders and notifications have been very helpful.

Cons

So far it has been very helpful. Not seen any issues. The system has lot of functionalities. We are planning to use the bar code labeling and scanning options.

Review Source

JD

Jeff D.  
Director of Operations: Sales and Marketing  
Medical Devices  
Used the software for: 6-12 months

### "Excellent Software "

August 15, 2020

5.0

Qualcy has made our calibration process smooth, stream-lined, and professional. Their software is designed to meet ISO standards, which we must follow in order to meet the demands of our clients--the top research institutes, hospitals, and biotechs across Southern California.

Pros

Intuitive Layout, Customizable Features, Dependable Customer Support

Cons

Nothing, it has exceeded my expectations

Review Source

Response from Qualcy Systems

September 14, 2020

Jeff, Thanks for the valuable feedback. We are always trying to exceed our customer's expectations.

SC

Samuel C.  
Chief Operating Officer  
Transportation/Trucking/Railroad  
Used the software for: 6-12 months

### "A Game-Changer for Quality Management "

August 22, 2023

5.0

Qualcy QMS has transformed the way we manage quality within our organization. The system's powerful features, such as document control and equipment management have enabled us to centralize our quality processes and eliminate the cumbersome manual methods we were using before.

Pros

One of the standout aspects of Qualcy QMS is its superior customer support. The support team went above and beyond to ensure that we had a successful implementation. They were responsive, knowledgeable, and genuinely dedicated to addressing our inquiries. What truly impressed me was their willingness to tailor their assistance according to our unique needs.

Cons

Cons: None observed so far.

Review Source

AP

Amy P.  
QA Manager  
Pharmaceuticals  
Used the software for: 6-12 months

### "Simple and easy to use Calibration management solution"

December 8, 2018

5.0

Very easy to use software for asset tracking and calibration management. Good compliance features for audit trails and Part 11 compliance.

Pros

It was easy to set up the system. It is easy to use with nice and clean user interface. The auto schedules for both calibration and PM have been very helpful. The reminders come to outlook inbox, makes it easy to track when something is coming due. The support from Qualcy team was great. We got the complete validation packet. The training support was very good. Qualcy support people are friendly and nice to work with.

Cons

The options for preventative maintenance can be improved. The attachment option for checklists are there. Built in templates would be helpful. We use lot of spare parts, tracking options for spare parts would also be helpful.

Review Source

JK

Jonson K.  
QC Head/Group Manager  
  
Used the software for: 6-12 months

### "It was easy and quick to get started. We had full guidance and support of SMEs which made it smooth"

June 16, 2018

5.0

Pros

It was easy to setup and intuitive to use. Support and guidance was available immediately. Lots of features and customization to suit our needs.

Cons

It seems to be in the industry for a long time. This inherently means it looks a bit outdated. Recently released version looks much more current and up to date.

Review Source

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