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About

Ideagen Please Review is document review and co-authoring software for regulated teams. It brings parallel and sequential reviews, feedback consolidation and version control into one secure, browser-based platform, so reviewers work against a single master document and accepted changes merge without version conflicts. Zone permissions control access down to paragraph level, including for external collaborators. Redaction is EMA Policy 70-ready. Every action, comment and change is captured in an audit trail, and document owners track progress through dashboards and notifications. Used by medical writers, regulatory affairs, quality assurance and bid teams in life sciences, aerospace and defense, healthcare and manufacturing. Integrates with Veeva Vault and Documentum D2 and runs natively inside Ideagen Quality Management. Reduces review time by up to 65%.

About

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Regulated teams that review and co-author critical documents, such as medical writers, regulatory affairs, quality assurance and bid teams

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

Ideagen
Founded: 1993
United Kingdom
www.ideagen.com/solutions/quality/document-review

Company Information

Qualitum
qualitum.ai

Alternatives

Alternatives

Foxit PDF Editor

Foxit PDF Editor

Foxit Software
Amici

Amici

Amici Procurement Solutions
Nutrient SDK

Nutrient SDK

Nutrient
Merit for Life Science

Merit for Life Science

Merit Solutions
Veeva Vault

Veeva Vault

Veeva Systems

Categories

Categories

Document Management Features

Access Controls Supported
Archiving & Retention Not Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Not Supported
Document Capture Not Supported
Document Conversion Not Supported
Document Delivery Not Supported
Document Indexing Not Supported
Document Retention Supported
Electronic Signature Not Supported
Email Management Not Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Not Supported
Full Text Search Not Supported
Offline Access Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Integrations

No info available.

Integrations

No info available.
Claim Ideagen Please Review and update features and information
Claim Ideagen Please Review and update features and information
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