Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
Trevally from ManualMaster is a comprehensive QHSE platform designed to cover the entire PDCA loop in a single web or on-premises solution. It provides controlled document and version management with audit trails, process mapping, risk and standard controls, as well as quality assurance registrations and smart web forms. Additional modules manage incidents, complaints, audits, deviations, tasks, and actions, all displayed in role-based dashboards with real-time KPIs, reports, and graphs. With ISO-27001 hosting, backups, single sign-on, two-factor authentication, and granular user permissions, Trevally ensures data security while supporting multi-language interfaces, digital signatures, and mobile access for enhanced user adoption.
API Access
Has API
No
API Access
Has API
Yes
Screenshots View All
No images available
Integrations
AFAS Software
No
Active Directory
No
GROW with SAP
No
HelloID
No
M3
No
Integrations
AFAS Software
Yes
Active Directory
Yes
GROW with SAP
Yes
HelloID
Yes
M3
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$6000/year
Free Trial
No
Free Version
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
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
ManualMaster
Founded
1992
Country
The Netherlands
Website
manualmaster.com
Product Features
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes