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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 GoVal?

GoVal is an AI-powered validation software purpose-built to digitize the full validation lifecycle across pharma, biotech, medical device, and other life science industries. From Computer System Validation (CSV), Equipment Qualification, and various validation requirements to broader GxP compliance needs, it leverages intelligent automation to deliver streamlined digital workflows—all within a secure, paperless framework. Its customizable platform with role-based workflows enables automated reviews, approvals, and real-time visibility, backed by compliant e-signatures and audit-ready traceability. Built to meet 21 CFR Part 11, EU Annex 11, and leading GxP standards, GoVal ensures seamless regulatory alignment. Risk-based strategies at the URS level empower teams to drive targeted mitigation planning and precise test case design. GoVal AI goes further—accelerating validation timelines through generative assistance for risk assessments, documentation, and test development. An in-built Document Management System (DMS) allows users to securely store, organize, and retrieve validation documents as needed—supporting data integrity, traceability, and effortless access during audits. Integrated deviation management, change tracking, and continuously updated data simplify inspections while reducing manual errors. The result: faster deployment, lower compliance costs, and stronger ROI—delivered with clarity, control, and continuous compliance.

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Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS
Android
iPhone

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Online Training
On-Site Training

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

AdventSys Technologies

Date Founded

2015

Company Location

India

Company Website

www.govalidation.com

Categories and Features

Life Sciences

Not specified

Categories and Features

Scientific Data Management System (SDMS)

Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
Workflows

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