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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
Our marketplace was developed to enhance the sourcing of regulated services effectively. With COMPLi®, organizations can establish a robust compliance framework that offers leadership reassurance about the integrity of sourcing across various research domains. The platform facilitates the automatic tracking of purchases, contract management, payment processing, and the integration of spending data into accounting systems. Recognized for its excellence, our platform aids pharmaceutical companies, biotech firms, and academic institutions in procuring regulated services and materials from external vendors. Whether you're involved in research, procurement, or service provision, COMPLi® is designed to address your compliance and governance challenges. Additionally, COMPLi® alleviates the administrative workload for providers of regulated services, fostering efficient customer interactions that ultimately lower expenses and expedite scientific inquiry. By enhancing compliance and governance across diverse regulated service sectors, COMPLi® empowers organizations to focus more on innovation and less on regulatory hurdles.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
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Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
Yes
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
Yes
iPad App
No
Android App
No
Windows
No
Mac
Yes
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)
Yes
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
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
Scientist.com
Country
United States
Website
scientist.com/enterprise/