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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

AmpleLogic eBMR differentiates itself through its flexible modular architecture and user-friendly low-code platform, providing customized solutions specifically designed for the pharmaceutical and biotechnology sectors. It boasts features such as real-time data integration, dispensing modules, and electronic signatures, which collectively ensure adherence to international regulatory requirements. By automating quality control processes, AmpleLogic eBMR enhances productivity, reduces compliance expenses, and simplifies the batch review process. Its electronic record-keeping capabilities minimize errors, leading to more accurate decision-making outcomes. Additionally, the software accelerates product modifications, aligns with regulatory standards, and boosts overall efficiency in pharmaceutical manufacturing. It allows for detailed specifications of raw materials and precise weight-age calculations, thereby optimizing material management through accurate dispensing methods. Furthermore, the system streamlines the routing, reviewing, and approving of manufacturing records, contributing to a more efficient batch review process that ultimately drives productivity levels higher. This comprehensive approach not only meets industry demands but also positions businesses for sustained growth.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Adobe Creative Cloud No 
HL7 FHIR No 

Integrations

Adobe Creative Cloud Yes 
HL7 FHIR 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 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 No 
Live Rep (24/7) No 
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 No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

AmpleLogic

Founded

2010

Country

India

Website

amplelogic.com/electronic-batch-record-software

Vendor Details

Company Name

Innovatum

Founded

1993

Country

United States

Website

www.innovatum.com

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