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What is Qualitum?
Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.
Media
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Integrations Supported
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Integrations Supported
Additional information not provided
API Availability
API Availability
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Supported Platforms
SaaS
Supported Platforms
SaaS
On-Prem
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Not specified
Training Options
Documentation Hub
Online Training
On-Site Training
Training Options
Not specified
Company Facts
Organization Name
TRiBECA Knowledge
Company Location
United Kingdom
Company Website
www.tribecaknowledge.com/smartlaunch-launch-readiness-software-for-pharmaceutical-and-biotech
Company Facts
Organization Name
Qualitum
Company Website
qualitum.ai
Categories and Features
Life Sciences
Not specified
Pharmaceutical and Biotech
Not specified
Categories and Features
Life Sciences
Not specified
Pharmaceutical and Biotech
Not specified