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Average Ratings 0 Ratings

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ease
features
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support

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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

An automated tool designed for the analysis and validation of cloud platforms catering to regulated sectors is now available. With just a few minutes of setup, review, and approval, you can save weeks of tedious manual validation tasks. Validify takes care of the entire process for you. Within minutes, Validify produces all necessary documentation, thereby removing the need for lengthy scheduling and preparation efforts. The tool not only identifies but also confirms any changes made to your applications. While vendors may validate their standard releases, your tailored solution requires a different approach. By ensuring that your platform remains compliant, Validify provides peace of mind and efficiency in maintaining regulatory standards. Consequently, this solution enables organizations to focus more on innovation rather than on prolonged compliance processes.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

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Integrations

Salesforce No 

Integrations

Salesforce Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$600 per month
Free Trial No 
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 No 
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 No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

Validify

Founded

2019

Country

Israel

Website

www.validify.app

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