Audience

Bio-Medical companies (including Biotech, Pharma and Medical Device)

About Qualcy QMS

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 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. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

Pricing

Starting Price:
$799 per month
Free Version:
Free Version available.
Free Trial:
Free Trial available.

Integrations

Ratings/Reviews - 1 User Review

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Videos and Screen Captures

CAPA home page

CAPA home page

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Product Details

Platforms Supported
SaaS
Windows
iPhone
iPad
Android
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
24/7 Live Support
Online

Qualcy QMS Frequently Asked Questions

Q: What kinds of users and organization types does Qualcy QMS work with?
Q: What languages does Qualcy QMS support in their product?
Q: What kind of support options does Qualcy QMS offer?
Q: What other applications or services does Qualcy QMS integrate with?
Q: Does Qualcy QMS have a mobile app?
Q: What type of training does Qualcy QMS provide?
Q: Does Qualcy QMS offer a free trial?
Q: How much does Qualcy QMS cost?
Q: What pricing for support is available for Qualcy QMS?
Q: What pricing for training is available for Qualcy QMS?

Qualcy QMS Product Features

Calibration Management

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

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Qualcy QMS Reviews

Write a Review
  • A Qualcy Bio-Med QMS Software User
    Director - Quality Assurance and Regulatory Compliance
    Used the software for: 2+ Years
    Frequency of Use: Daily
    User Role: User, Administrator, Deployment
    Company Size: 1 - 25
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Good QMS software"

    Posted 2021-02-24

    Pros: Simple and easy to manage the document change controls. Integrated training module automates the training records. The QMS package comes with calibration and asset management module, which is a big plus.

    Cons: It took us little longer than expected to get started. It has been a good experience so far.

    Overall: Good software for biotech companies. The built in compliance and part 11 features are big help. Good support from the Qualcy team.

    Read More...