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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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

Tailored for the life sciences sector, the eTraininfo Training Management System streamlines training operations to enhance compliance and boost productivity. Fully compliant with 21 CFR Part 11, eTraininfo supports the paperless management and tracking of training records. To facilitate rapid system validation and deployment, a comprehensive validation package crafted by experts is provided. This detailed package ensures swift and straightforward implementation. Understanding the significance of data migration in validating any software system, CS offers specialized services for the preparation and execution of Data Migration Protocols, which are essential for the data transition process. Additionally, the product specialists at CS are available to guide you in optimizing your eInfotree implementation, ensuring you achieve the highest return on investment through a deep understanding of business processes and industry best practices. By leveraging their expertise, organizations can fully harness the capabilities of the eTraininfo system.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

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Screenshots View All

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 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 No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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 No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

CIMINFO Software

Founded

1988

Country

United States

Website

www.part11solutions.com

Product Features

Training

Academic / Education No 
Asynchronous Learning Yes 
Blended Learning No 
Built-In Course Authoring No 
Built-in LMS Yes 
Certification Management Yes 
Corporate / Business No 
Learner Portal No 
Mobile Learning No 
Simulation No 
Synchronous Learning No 
Training Companies No 
eCommerce No 

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