Average Ratings 0 Ratings
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
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
No images available
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
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