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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.

What is Mosaic Solutions Group?

Mosaic provides an all-encompassing commercial data management solution that acts as a reliable Single-Source-of-Truth, effectively combining customer master data management with business intelligence. This service allows pharmaceutical companies to bypass the challenge of choosing between costly, time-intensive consulting projects and the cumbersome overhead of traditional SaaS solutions. With Mosaic, clients enjoy a personalized experience and customized solutions similar to consulting services, while also benefiting from the financial predictability associated with SaaS offerings. This groundbreaking model empowers pharmaceutical firms to improve their operational efficiency without sacrificing quality or the ability to tailor solutions to their specific needs. Ultimately, Mosaic positions itself as a strategic partner in the ever-evolving landscape of data management for the pharmaceutical industry.

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Integrations Supported

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Integrations Supported

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API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

Windows
Mac
Linux

Customer Service / Support

Not specified

Customer Service / Support

Standard Support

Training Options

Not specified

Training Options

Not specified

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

Mosaic Solutions Group

Date Founded

2010

Company Location

United States

Company Website

mosaicsg.com

Categories and Features

Life Sciences

Not specified

Categories and Features

Life Sciences

Not specified

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