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.
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Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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Pricing
Starting Price:
$799 per month
Free Version:
Free Version available.
Free Trial:
Free Trial available.
Integrations
Company Information
Qualcy Systems
Founded: 2014
United States
www.qualcy.com
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Product Details
Platforms Supported
Cloud
Windows
iPhone
iPad
Android
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
24/7 Live Support
Online
Qualcy QMS Frequently Asked Questions
Qualcy QMS Product Features
Calibration Management
Calibration Instructions
Supported
Calibration Schedules
Supported
Compliance Management
Supported
Due Date Tracking
Supported
Gage Management
Supported
Label Printing
Supported
Device History
Not Supported
Measurement Readings
Not Supported
Multi-Station Management
Not Supported
Out-of-Tolerance Notification
Not Supported
Statistical Data Reporting
Not Supported
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Qualcy QMS Additional Categories
Qualcy QMS Verified User Reviews
Write a Review-
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.
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