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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 Ideagen Please Review?

Ideagen Please Review is document review and co-authoring software for regulated teams, with redaction and a full audit trail built in. It replaces email chains and manual comment consolidation with one secure, browser-based place to review, approve and sign off documents. Key benefits: - Faster reviews: parallel or sequential workflows, with feedback consolidated in one workspace. Reduces review time by up to 65%. - Fewer version conflicts: reviewers work against a single master document and accepted changes are applied automatically. - Tighter control: paragraph-level permissions, secure external collaboration and EMA Policy 70-ready redaction. - Audit-ready records: every action, comment and change is captured, with instant audit reports. Runs natively inside Ideagen Quality Management and integrates with Veeva Vault.

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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

Customer Service / Support

Not specified

Customer Service / Support

Not specified

Training Options

Not specified

Training Options

Not specified

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

Ideagen

Date Founded

1993

Company Location

United Kingdom

Company Website

www.ideagen.com/solutions/quality/document-review

Categories and Features

Life Sciences

Not specified

Categories and Features

Document Management

Access Controls
Collaboration Tools
Compliance Tracking
Document Archiving
Document Retention
File Recovery
File Type Conversion
Offline Access
Version Control

PDF Redaction

Not specified

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