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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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.

Description

Quality is a never-ending journey, requiring a deliberate effort to maintain a competitive edge in today's business landscape. In critical sectors such as pharmaceuticals, the acceptance, regulatory approvals, and overall success heavily depend on maintaining high-quality standards. The pharmaceutical realm is characterized by rigorous regulations that add layers of complexity to the management of business operations. To effectively navigate this landscape, it is essential to continually assess and innovate internal processes. An integrated quality management system becomes vital in this context. GMPPro, developed by Motto Systems, serves as a comprehensive and reliable quality management solution tailored to address quality challenges at every phase of drug development. This sophisticated system not only covers the entire scope of production, quality control, quality assurance, and engineering but can also function as modular independent solutions. GMPPro is engineered to ensure complete oversight of processes and is supported by our dedicated team of industry professionals, ensuring that quality remains at the forefront of pharmaceutical development. By leveraging such advanced systems, companies can better position themselves for success in a highly regulated environment.

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

Arena, a PTC Business

Founded

2000

Country

United States

Website

www.arenasolutions.com/platform/qms/

Vendor Details

Company Name

Motto Systems

Founded

2013

Country

India

Website

www.mottosys.com/gmppro-suite.html

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

Product Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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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