Qualcy QMS Overview
What is Qualcy QMS?
Qualcy Bio-Med QMS Software is a specialized Quality Management System engineered explicitly for the bio-medical sector, encompassing biotech, pharmaceuticals, and medical devices. It is pre-configured to manage QMS records in alignment with stringent regulations, primarily ISO 13485 and FDA requirements, including 21 CFR Part 820. The software includes built-in capabilities essential for compliance, such as electronic signatures (E-sign), comprehensive audit trails, and adherence to 21 CFR Part 11 for electronic records. It provides structured modules to manage critical quality processes including Document Change Control, Complaints, Audits, CAPA (Corrective and Preventive Action), Nonconformance Records, and Employee Training Records.
Who it's for:
Qualcy QMS is exclusively for bio-medical companies—such as medical device manufacturers, pharmaceutical firms, and biotech startups—that operate under strict FDA and ISO 13485 regulations. It is designed for Quality Assurance and Regulatory Affairs professionals who need a purpose-built system to ensure compliance and streamline quality processes from the outset.
Our verdict:
Qualcy QMS is a focused and compliant solution that delivers precisely what regulated bio-medical companies require. Its out-of-the-box configuration for key standards makes it a efficient choice for ensuring quality system integrity and simplifying the path to regulatory approval and maintenance.
Qualcy QMS Details
Qualcy QMS Platforms supported
Cloud, SaaS, Web-Based
Desktop Mac
Desktop Windows
Mobile Android
Mobile iPad
Mobile iPhone
On-Premise Linux
On-Premise Windows
Desktop Chromebook
Desktop Linux
Qualcy QMS Support options
Chat
Email Help Desk
Phone Support
Qualcy QMS Training options
Documentation
In-Person
Live Online
Webinars
Videos
Qualcy QMS Related Categories
Qualcy QMS Typical customers
Freelancers
Small Businesses
Small to Mid size businesses
Mid size businesses
Mid to Large size enterprises
Large enterprises
Very Large enterprises
Qualcy QMS Pricing
Tiered pricing system
Qualcy QMS Features
Most valued Qualcy QMS features by users
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Coding & Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Alerts/Notifications
Asset Tracking
Audit Planning
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
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