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Average Ratings 0 Ratings

Total
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

When production instructions change, the work does not end with a revised document. Production needs a usable process, QA needs a clear record, and IT/OT needs a solution that fits the plant. anicomply is an eBR-first Intelligence Platform built around that shared challenge in regulated manufacturing. Existing, structured Microsoft Word recipes and manufacturing instructions become the foundation for executable digital batch workflows, not just electronic copies of paper records. A declarative, no-code-oriented approach helps process teams create and adjust workflows with less reliance on custom programming. Depending on configuration, audit trails, electronic signatures, version control and four-eyes review support controlled processes. Structured execution data can make events easier to trace and help QA focus on exceptions during batch review. The browser-based application supports mobile use and deployment in the cloud or on premises. Integration with ERP, MES and SCADA systems is assessed and scoped to the specific project. anicomply is relevant to pharmaceutical and biotech manufacturers, CMOs, CDMOs, API producers and quality-critical chemical operations with changing recipes or product variants.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

Rimsys Yes 

Integrations

Rimsys No 

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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

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 Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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