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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.

About

End-to-end Product and Process Data Management. Skyland PIMS® provides emerging & global drug sponsors and CMOs a collaborative workspace to manage critical development, manufacturing and quality data. Our cloud-based, validatable software allows for fast deployment and low TCO. Maintain data content, understanding, and control across the supply chain. Faster and more efficient scale-ups, tech transfers, and commercial releases. Capture batch data and access summary dashboards for data monitoring, release status, analysis and reporting. Manage product and process specifications and target control limits. Easily create an audit trail. Automatically integrate Batch and Limits data to produce process analysis and control charts. Fulfill CPV/APR reporting requirements. Persistent product and process data library for data transparency and integrity across global networks. Streamline product and process data management throughout the product lifecycle and supply chain.

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

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

Audience

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

Audience

Organizations interested in intuitive solutions to increase visibility and streamline data management and analytics throughout the product life cycle and supply chain

Support

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

Support

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

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

No images available

Screenshots and Videos

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 Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Qualitum
qualitum.ai

Company Information

IDBS
Founded: 1989
United Kingdom
skylandanalytics.net

Alternatives

Alternatives

Amici

Amici

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WATS

WATS

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Merit for Life Science

Merit for Life Science

Merit Solutions
Veeva Vault

Veeva Vault

Veeva Systems

Categories

Categories

Integrations

No info available.

Integrations

No info available.
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