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Average Ratings 0 Ratings

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ease
features
design
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

Integrated digital asset management tailored for the life sciences sector facilitates worldwide resource sharing and decreases expenditures on marketing materials. Marketing teams have the capability to efficiently publish and retract content across various digital platforms while ensuring that only sanctioned assets are utilized. By leveraging top-tier medical, legal, and regulatory (MLR) processes, organizations can expedite content approval and reduce time to market. An integrated claims library complete with reference links alleviates the administrative load and mitigates risks associated with managing claims across different regions, platforms, and content types. Our industry-specific cloud solutions deliver crucial data, software, services, and a vast network of partners to enhance your essential functions from research and development to commercialization. Veeva empowers businesses, regardless of size, to accelerate their product launches while ensuring compliance and operational efficiency. This comprehensive approach not only streamlines processes but also fosters collaboration among teams, significantly enhancing overall productivity.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

Integrations

Adobe Acrobat No 
Lyriko No 
Red Marker No 
Symmetryk No 

Integrations

Adobe Acrobat Yes 
Lyriko Yes 
Red Marker Yes 
Symmetryk 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 Yes 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

Veeva Systems

Country

United States

Website

www.veeva.com/products/vault-promomats/

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