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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

QuartzBio is a precision-medicine intelligence platform designed to transform how clinical development and translational research teams work by providing a unified data ecosystem where biospecimen, biomarker, and clinical data can be ingested, harmonized, explored, and interrogated via conversational AI. Powered by its Precision Medicine AI Agent Platform, QuartzBio includes key solutions like Sample Intelligence, which offers a 360° view of biospecimen lifecycles from collection to long-term storage and uses automated logistics, stability monitoring and data-reconciliation tools; and Biomarker Intelligence, which delivers unified ingestion of assay data across DNA, RNA, protein and cell-based modalities, a no-code data-mapper, global search, dashboards, visual analytics and genomic/cytometry modules; additionally, the Agent Intelligence layer enables natural-language queries across the data asset so stakeholders.

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

Translational research and biomarker teams requiring a tool to centralize sample and biomarker data, accelerate insight generation and support precision-medicine decision-making

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 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 Supported
Live Online Supported
In Person Not Supported

Company Information

Qualitum
qualitum.ai

Company Information

QuartzBio
United States
www.quartz.bio/

Alternatives

Alternatives

Amici

Amici

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Merit for Life Science

Merit for Life Science

Merit Solutions
Veeva Vault

Veeva Vault

Veeva Systems
XetaBase

XetaBase

Zetta Genomics

Categories

Categories

Integrations

No info available.

Integrations

No info available.
Claim Qualitum and update features and information
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