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features
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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

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

Screenshots View All

Integrations

Scandit No 
Tapstream No 

Integrations

Scandit Yes 
Tapstream Yes 

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/

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