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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

Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Rimsys

Integrations

Rimsys

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

AmpleLogic

Founded

2010

Country

India

Website

amplelogic.com/electronic-batch-record-software

Vendor Details

Company Name

Arena, a PTC Business

Founded

2000

Country

United States

Website

www.arenasolutions.com/platform/qms/

Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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