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Description
Innovatum provides a thorough labeling and regulatory-data management solution tailored for companies in the life sciences sector, such as those involved in pharmaceuticals, medical devices, and biotechnology manufacturing. Central to their offering is the ROBAR platform, which acts as an enterprise-level label management system facilitating every phase of the label lifecycle, from master-data management (PIMS/MDM) and artwork/version control (with native capabilities for managing Adobe files) to regulatory-data submissions (including UDI/MDR/IVDR/Eudamed and GS1 data pool) and culminating in final label printing, print-inspection integration, and compliant archiving. The platform is designed to be configurable, allowing for enhancements to be added to the core product without necessitating rework during upgrades, and it can be deployed through on-premises, hosted, or single-tenant cloud/SaaS configurations, accommodating various IT infrastructure preferences. Additionally, Innovatum features an eLabeling (eIFU) module that connects products, their versions, and translations to electronic instructions for use, enhancing user accessibility and compliance. This comprehensive system not only streamlines processes but also ensures regulatory adherence for its users.
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.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Adobe Creative Cloud
No
HL7 FHIR
No
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
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
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
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Innovatum
Founded
1993
Country
United States
Website
www.innovatum.com
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
