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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
anicomply is a dynamic Electronic Batch Record (EBR) system tailored for pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs/CMOs), active pharmaceutical ingredient (API) producers, and various other industries where quality is paramount.
This platform digitizes traditional paper-based or hybrid batch processes into efficient, executable workflows, distinguishing itself with remarkable speed; a standard recipe can be converted from a standard operating procedure (SOP) into an active digital workflow in just a matter of hours, rather than taking weeks.
By employing a declarative methodology, process owners can implement numerous workflow modifications with minimal reliance on developers, which significantly decreases the need for programming, reduces iteration cycles, and alleviates resource constraints.
The system is designed with essential features such as an integrated audit trail, electronic signatures, version control, and a four-eyes review process to meet GxP compliance requirements inherently.
As a web-based application, it operates seamlessly across various devices and offers both cloud and on-premises deployment options, while also integrating smoothly with ERP, MES, and SCADA systems.
Additionally, anicomply generates structured process data that enhances review-by-exception, ensures traceability, facilitates analytics, and lays the groundwork for future artificial intelligence applications.
This comprehensive functionality not only improves operational efficiency but also bolsters regulatory compliance in manufacturing processes.
API Access
Has API
API Access
Has API
Screenshots View All
No images available
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
anic GmbH
Founded
1996
Country
Germany
Website
www.anic-gmbh.de
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