Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No images available
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