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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

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

ysura conceives and develops innovative Sales and Marketing Solutions for the Pharmaceutical Industry and offers them as a Software-as-a-Service. Founded in 2012, ysura is based in Munich. It employs over 60 people from 17 countries. Ysura, an old Celtic word meaning Isar, is the name of the river that flows through Munich. It is a combination of ys (fast water) and ura(water). Ysura is short for fast water. Our products are fast and adaptable to the flow of information and tasks in the life sciences industry.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

No images available

Screenshots View All

Integrations

SAP ERP No 
Salesforce No 
Veeva CRM No 

Integrations

SAP ERP Yes 
Salesforce Yes 
Veeva CRM Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$35.00/month/user
Depending on the modules, from $35.00/month/user
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 Yes 
iPad App Yes 
Android App Yes 
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) Yes 
In Person Yes 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

ysura

Founded

2012

Country

Germany

Website

www.ysura.com

Product Features

CRM

Calendar/Reminder System Yes 
Call Logging Yes 
Document Storage Yes 
Email Marketing Yes 
Internal Chat Integration Yes 
Lead Scoring Yes 
Marketing Automation Integration Yes 
Mobile Access Yes 
Quotes / Proposals No 
Segmentation Yes 
Social Media Integration Yes 
Task Management Yes 
Territory Management Yes 

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