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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
In the rapidly evolving world of regulatory requirements, Titanium presents an all-encompassing array of applications specifically designed to ensure that your sample management program remains compliant, efficient, and streamlined. Discover the exceptional advantages of our SaaS platform, which leverages cloud technology to provide innovative solutions that adhere to both PDMA and 21 CFR Part 11 standards. With a versatile suite of applications, Titanium effectively tackles various compliance hurdles while ensuring smooth interoperability, thus delivering a holistic and cohesive approach to meet your compliance demands. Our platform is engineered to adapt as your business expands, guaranteeing that each data entry is singular and universally accessible across all applications. Enhance transparency and accountability with integrated audit trails that facilitate effortless tracking and reporting. As a well-established application, Titanium continually advances through regular updates, ensuring that you remain at the cutting edge of compliance technology. Furthermore, we prioritize user feedback to adapt and refine our offerings, empowering clients to navigate the complexities of compliance with confidence.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Scandit
No
Tapstream
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
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
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
QPharma
Country
United States
Website
qpharmacorp.com/products/titanium/