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
Safeguard your enterprise and adhere to country-specific drug serialization mandates and rapidly evolving regulations while effectively managing vast data quantities with smart solutions. Utilize the SAP Advanced Track and Trace for Pharmaceuticals application to ensure compliance with both international and local laws, as it features a comprehensive serialization repository, efficient serial number management, and robust regulatory reporting functions. Lower the costs associated with compliance for both current and future serialization obligations, including specific reporting requirements for various nations. Enhance your supply chain's productivity by gaining deeper insights into the movement of materials, all the way down to the sales-unit-item level. Efficiently manage extensive serialization data while staying agile enough to embrace new legislative changes. Maintain oversight of retail product serial numbers within a centralized corporate repository, ensuring that you meet all country-specific regulations when it comes to reporting these serial numbers. By implementing these strategies, your business can not only streamline operations but also stay ahead in a competitive market.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Nextbitt
No
SAP Joule
No
Streams.AI by PanTerra Networks
No
TrueCommerce
No
Integrations
Nextbitt
Yes
SAP Joule
Yes
Streams.AI by PanTerra Networks
Yes
TrueCommerce
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)
No
In Person
No
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
SAP
Founded
1972
Country
Germany
Website
www.sap.com/products/track-trace-pharmaceuticals.html