Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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

Screenshots View All

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

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 

Alternatives

Amici Reviews

Amici

Amici Procurement Solutions

Alternatives

Merit for Life Science Reviews

Merit for Life Science

Merit Solutions
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences