What is Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

Pricing

Price Starts At:
$799 per month
Free Version:
Free Version available.
Free Trial Offered?:
Yes

Screenshots and Video

CAPA home page

CAPA home page

Company Facts

Company Name:
Qualcy Systems
Date Founded:
2014
Company Location:
United States
Company Website:
www.qualcy.com
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Product Details

Deployment
SaaS
Windows
iPhone
iPad
Android
Training Options
Documentation Hub
Online Training
Webinars
On-Site Training
Support
Standard Support
24 Hour Support
Web-Based Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
Target Organization Types
Mid Size Business
Small Business
Enterprise
Nonprofit
Government
Startup
Supported Languages
English

Qualcy QMS Categories and Features

Quality Management Software

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

Calibration Management Software

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 QMS Customer Reviews

Write a Review
  • Reviewer Name: A Verified Reviewer
    Position: Director - Quality Assurance and Regulatory Compliance
    Has used product for: 2+ Years
    Uses the product: Daily
    Org Size (# of Employees): 1 - 25
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Good QMS software

    Date: Feb 24 2021
    Summary

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

    Positive

    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.

    Negative

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

    Read More...
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