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About

At H1, our mission is nothing short of creating a healthier future worldwide by unlocking and democratizing global access to critical expertise, HCP information, claims data, ground-breaking research and discoveries, and connected insights for all – doctors, researchers, industry and, ultimately, patients – bringing everyone closer together to advance medicine and clinical outcomes. Insights derived from H1’s solutions help life sciences and other healthcare organizations accelerate the development, launch, and dissemination of life-saving treatments, drive meaningful engagements with key opinion leaders, and help ensure equitable access to healthcare services.

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

Pharmaceutical, biotech, CROs, medical device, health plans & digital health companies

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 Supported

Support

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

API

Offers API 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 Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Training

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

Company Information

H1
Founded: 2017
United States
www.h1.co

Company Information

Qualitum
qualitum.ai

Alternatives

Alternatives

Amici

Amici

Amici Procurement Solutions
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.
Claim H1 and update features and information
Claim H1 and update features and information
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