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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 AVEVA Data Hub?

To boost operational efficiency, encourage sustainable practices, and support digital transformation, organizations need to identify cost-effective methods for gathering, storing, and distributing crucial industrial data. By integrating and analyzing this data, companies can achieve deep insights and securely communicate them with trusted partners both inside and outside their organizations to foster collaboration. Leveraging the software-as-a-service (SaaS) capabilities of our industrial cloud platform, AVEVA Connect, the AVEVA Data Hub removes barriers to data sharing by utilizing the scaling and flexibility offered by cloud technology. This platform provides users with secure, real-time access to data, independent of their location or network connection. As a fully managed, cloud-native SaaS solution, AVEVA Data Hub is ready to use immediately and can expand as required without the need for extra infrastructure or IT staff. Designed for smooth integration with AVEVA™ PI System, AVEVA™ Historian, and Edge Data Store, companies can transition their operational data to the cloud at a comfortable pace, all while promoting ongoing advancements. This functionality not only enhances decision-making but also stimulates innovation throughout the organization, making it a valuable asset for future growth. Ultimately, embracing such cloud solutions positions organizations to thrive in an increasingly data-driven environment.

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Integrations Supported

Integrations Supported

AVEVA Connect
AVEVA Historian
AVEVA PI System
PARCview
Rayven

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

AVEVA

Company Location

Untied Kingdom

Company Website

www.aveva.com/en/products/aveva-data-hub/

Categories and Features

Life Sciences

Not specified

Categories and Features

Data Management

Not specified

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