Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
KOŚA DMS is a comprehensive cloud document management solution tailored for organizations in the pharmaceutical, biotechnology, medical device, and broader life sciences sectors. It facilitates the creation, evaluation, authorization, distribution, and revision tracking of controlled documents, incorporating workflows for standard operating procedures (SOPs), policies, forms, and other essential quality records. With the ability to manage role-specific access, electronic signatures, audit trails, and periodic reviews, teams can ensure that document histories remain traceable for regulated processes. Integration with Microsoft Word enhances the drafting process, allowing users to work within a familiar authoring environment, while connections to ERP and LIMS systems enable seamless documentation linkage with operational workflows. Designed specifically for quality assurance, quality control, regulatory affairs, and document control teams, this system streamlines the coordination of document lifecycle activities across various sites and functions, ensuring compliance with industry regulations. Furthermore, the platform's user-friendly interface allows teams to efficiently navigate and manage their document processes without unnecessary complications.
API Access
Has API
No
API Access
Has API
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
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
No
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
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Vendor Details
Company Name
Innovatum
Founded
1993
Country
United States
Website
www.innovatum.com
Vendor Details
Company Name
KOŚA
Founded
2025
Country
India
Website
kosa-ai.com/pharmaceutical-document-management-system/
Product Features
Product Features
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No