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ease
features
design
support

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Write a Review

Description

Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.

Description

Verana Health operates as a platform for real-world data that converts both structured and unstructured information from electronic health records into curated, de-identified, disease-focused data modules through its clinician-informed and AI-enhanced VeraQ population health data engine. By aggregating data from key collaborations with prominent medical registries, including the American Academies of Ophthalmology, Neurology, and Urological Association, the platform integrates insights from over 20,000 clinicians and approximately 90 million patient records, thereby supplying high-quality datasets in near real-time for the purposes of generating real-world evidence, identifying clinical trial sites and subjects, reporting clinician quality, and managing medical registries. Users can access this wealth of information through cloud services like AWS Data Exchange and Amazon Redshift, which provide self-service API access, a user-friendly dashboard, and tools for customizable cohort discovery. Furthermore, the system employs advanced AI and machine learning algorithms along with comprehensive data quality assessments to ensure the reliability and accuracy of the information provided. This innovative approach not only facilitates efficient data utilization but also enhances the overall quality of healthcare research and practice.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

No images available

Screenshots View All

Integrations

AWS Data Exchange No 
Amazon Redshift No 

Integrations

AWS Data Exchange Yes 
Amazon Redshift Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

Verana Health

Country

United States

Website

veranahealth.com

Product Features

Population Health Management (PHM)

Analytics No 
Cost-of-Care Analysis No 
Data Storage No 
EMR/EHR Integration No 
Patient Engagement No 
Patient Identification No 
Patient Risk Stratification No 
Patient-Reported Outcomes No 
Payment Bundling No 
Predictive Alerts No 
Test & Treatment Reminders No 
Utilization Tracking No 

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