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Average Ratings 0 Ratings
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
No images available
Integrations
Salesforce
No
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