Best For

Biotech, medical device and other regulated industries.

Product Details

* Qualcy CAL/PM Software has been helping Complex Engineering, Bio-Medical applications and Pharma companies manage the QMS records easily for ISO and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. The software also helps manage the CAL, PM, OOT Records for Complex Engineering, Bio-Medical applications and Pharma companies

Contact Details

Qualcy Systems

http://www.qualcy.com

Founded in 2014

Located in United States

No Media

Starting Price

  • $99.00/month/user
  • $99/Mo user- 3 users $79/Mo /user- 4 to 10 users $69/Mo/ user- 10 +

Platform

  • Installed - Mac
  • Cloud, SaaS, Web
  • Installed - Windows
  • Mobile - iOS Native
  • Mobile - Android Native

Training

  • In Person
  • Live Online
  • Webinars
  • Documentation

Support

  • Business Hours
  • Online

Qualcy Bio-Med CAL/PM Solutions Features

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Qualcy Bio-Med CAL/PM Solutions Reviews

Overall
5/5
Ease of Use
4.5/5
Customer Service
4.5/5

Showing Most Helpful

Showing 6 of 6 reviews

Showing Most Helpful

Showing 6 of 6 reviews

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Rating
Company Size
Reviewer's Role
Length of Use
Frequency of Use
Jeffrey B.
Quality and Compliance Manager
Biotechnology, 51-200 employees
Used the software for: 2+ years
Overall Rating
5/5
Ease of Use
5/5
Customer Service
5/5
Features
4/5
Value for Money
5/5
Likelihood to Recommend
10/10
Reviewer Source 
Source: Capterra
August 27, 2018

“Robust Part 11 compliance ”

OverallRobust compliance features for part11 compliance. Easy to use. Very good technical support.
ProsThe 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.
ConsInitially 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.
Reviewer Source 
Source: Capterra
August 27, 2018
Antony H.
Quality Manager
Pharmaceuticals, 51-200 employees
Used the software for: 1-2 years
Overall Rating
5/5
Ease of Use
5/5
Customer Service
4/5
Features
4/5
Value for Money
5/5
Likelihood to Recommend
9/10
Reviewer Source 
Source: Capterra
August 14, 2018

“Calibration PM software that best meets ours needs”

OverallOverall smooth on-boarding and transition. Training was very effective and helpful.
ProsThe 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.
ConsIt 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.
Reviewer Source 
Source: Capterra
August 14, 2018
Samuel H.
Director, QA and Compliance
Medical Devices, 11-50 employees
Used the software for: 2+ years
Overall Rating
5/5
Ease of Use
4/5
Customer Service
5/5
Features
4/5
Value for Money
5/5
Likelihood to Recommend
9/10
Reviewer Source 
Source: Capterra
August 21, 2018

“Flexible and user friendly”

OverallOverall very satisfied. It is a good program.
ProsThe 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.
ConsExpensive compared to other options we looked at. The cost included validation package, training support and data migration. I think it is well worth it.

Vendor Response

By Qualcy Systems on August 26, 2018
Thanks for the positive feedback.
Reviewer Source 
Source: Capterra
August 21, 2018
Margie B.
Sr. Quality Manager
Unspecified
Used the software for: 2+ years
Overall Rating
5/5
Ease of Use
5/5
Customer Service
5/5
Features
4/5
Value for Money
4/5
Reviewer Source 
Source: Capterra
June 13, 2018

“Very helpful, simple and easy to use”

ProsWe 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.
ConsSo 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.
Reviewer Source 
Source: Capterra
June 13, 2018
Amy P.
QA Manager
Pharmaceuticals, 51-200 employees
Used the software for: 6-12 months
Overall Rating
5/5
Ease of Use
5/5
Customer Service
5/5
Features
4/5
Value for Money
4/5
Likelihood to Recommend
10/10
Reviewer Source 
Source: Capterra
December 7, 2018

“Simple and easy to use Calibration management solution”

OverallVery easy to use software for asset tracking and calibration management. Good compliance features for audit trails and Part 11 compliance.
ProsIt 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.
ConsThe 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.
Reviewer Source 
Source: Capterra
December 7, 2018
Jonson K.
QC Head/Group Manager
Unspecified
Used the software for: 6-12 months
Overall Rating
5/5
Ease of Use
4/5
Customer Service
4/5
Features
5/5
Value for Money
5/5
Reviewer Source 
Source: Capterra
June 16, 2018

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

ProsIt was easy to setup and intuitive to use. Support and guidance was available immediately. Lots of features and customization to suit our needs.
ConsIt 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.
Reviewer Source 
Source: Capterra
June 16, 2018