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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

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

Screenshots View All

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

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