Qualcy QMS

RATING:

4.9

(17)

About Qualcy QMS

Qualcy eQMS application is simple and easy to use, designed for Bio-Med and Life Science industry requirements. This software helps maintain compliance readiness, and enables proactive problem solving with visual metrics and notifications. The Qualcy eQMS helps users do more things with less time and resources. This software is fully compliant with 21 CFR Part 11 requirements. Qualcy Systems provides validation package including IQ/OQ reports for compliance with 21 CFR 820, 21 CFR 210/211 requirements. This software is delivered either through Cloud or On-premise hosting options. The Qualcy eQMS modules includes Doc. Management, Change Control, Training Management, CAPA, Audits, NC Management, Equipment Management, Supplier Quality Management and others. ...

Qualcy QMS Pricing

Number of users X $price/month = your $price/month Small Business: $99/month for 3 selected modules and up to 10 users Medium Business: $69/month for 4 selected modules and 11 to 100 users Medium and Large Enterprise: $49/month for 5 modules and 101-1000+ users

Starting price: 

$99.00 per month

Free trial: 

Available

Free version: 

Available

Qualcy eQMS CAPA module with metrics

Qualcy QMS Reviews

Overall Rating

4.9

Ratings Breakdown

Secondary Ratings

Ease-of-use

4.5

Customer Support

5

Value for money

5

Functionality

4.5

Most Helpful Reviews for Qualcy QMS

1 - 5 of 17 Reviews

Kelly

Hospital & Health Care, 2-10 employees

Used daily for less than 6 months

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed April 2020

Best program out there

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.

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.

Vendor Response

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

Replied September 2020

Maraea

Hospital & Health Care, 11-50 employees

Used daily for more than 2 years

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed March 2022

Excellent product and Excellent support team

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

Vendor Response

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

Replied April 2022

Carl

Medical Devices, 2-10 employees

Used daily for less than 12 months

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

4

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

Reviewed November 2022

Qualcy eQMS

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.

Vendor Response

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.

Replied January 2023

Jeffrey

Biotechnology, 51-200 employees

Used daily for more than 2 years

Review Source: Capterra
This review was submitted organically. No incentive was offered

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

Reviewed August 2018

Robust Part 11 compliance

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.

Mark

Biotechnology, 11-50 employees

Used daily for more than 2 years

Review Source: Capterra
This reviewer was invited by the software vendor to submit an honest review.

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

4

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed August 2020

Qualcy eQMS software

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.