Qualcy QMS Description

Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.

Pricing

Pricing Starts At:
$799 per month
Free Version:
Yes
Free Trial:
Yes

Integrations

View Integrations

Reviews - 1 Verified Review

Total
ease
features
design
support
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Company Details

Company:
Qualcy Systems
Year Founded:
2014
Headquarters:
United States
Website:
www.qualcy.com
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Media

CAPA home page

CAPA home page

CAPA home page Doc Mgmt Training mgmt Metrics page Notification page
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Product Details

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

Qualcy QMS Features and Options

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 User Reviews

Write a Review
  • Name: Anonymous (Verified)
    Job Title: Director - Quality Assurance and Regulatory Compliance
    Length of product use: 2+ Years
    Used How Often?: Daily
    Role: User, Administrator, Deployment
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...