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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Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
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▶ Training Management
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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
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 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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