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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.
Description
Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
AWS Backup
Yes
AWS Cloud9
Yes
Gmail
Yes
Microsoft 365
Yes
Microsoft Azure
Yes
Microsoft Outlook
Yes
SAP Analytics Cloud
Yes
Integrations
AWS Backup
No
AWS Cloud9
No
Gmail
No
Microsoft 365
No
Microsoft Azure
No
Microsoft Outlook
No
SAP Analytics Cloud
No
Pricing Details
$799 per month
Free Trial
Yes
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Qualcy Systems
Founded
2014
Country
United States
Website
www.qualcy.com
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
No
Due Date Tracking
Yes
Gage Management
Yes
Label Printing
Yes
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Alternatives
Alternatives
No Alternatives