Arena for Quality System Management
Updated July 06, 2022
Arena for Quality System Management
Score 8 out of 10
Vetted Review
Verified User
Overall Satisfaction with Arena
We use Arena across the quality, regulatory and operations departments to control product design and manage the Quality System.
- Bill of material.
- Quality module - CAPA Workflow.
- Quality module - Risk Management File/Design History File/Device Master Record.
- The reporting interface is fairly weak. We export to Excel to organize and sort the data.
- Linkage could be improved. I'd like to ability to link to closed workflows within the Quality Module.
- We're able to use Arena for both Operations and Quality/Regulatory, so we're saving money not having to purchase and maintain dual software.
- Price
- Product Features
- Product Usability
When we were deciding on software, the validation package and support made the difference between this software and the competitor. Our validation workload were and continue to be minimal.
We implemented the BOM first and then added Quality Modules slowly over 5 years. It was easy to implement with minimal outside expertise.
Do you think Arena PLM and QMS delivers good value for the price?
Yes
Are you happy with Arena PLM and QMS's feature set?
Yes
Did Arena PLM and QMS live up to sales and marketing promises?
Yes
Did implementation of Arena PLM and QMS go as expected?
Yes
Would you buy Arena PLM and QMS again?
Yes
I've used Trackwise and Qualtrax previously, and the direct competitor for Arena originally was Q-Pulse.
Using Arena
We use Arena for the following ISO and FDA Quality System applications:
Document Control, Design History File, Device Master Record, Risk Management File, Usability/Human Factors Engineering File, Nonconformance Reporting, CAPA, Audit Observations, Complaint Investigations
Document Control, Design History File, Device Master Record, Risk Management File, Usability/Human Factors Engineering File, Nonconformance Reporting, CAPA, Audit Observations, Complaint Investigations
Since all reviewers were already familiar with Arena, the review and approval process was almost not impacted by the change to remote working in Q1. Arena remains our most important cross-functional software tool.
We started with the BOM and incorporated Document Control using the Item module. We've expanded into the Quality Module for most Quality processes and used the Supplier module for supplier tracking.
Arena is a strong tool for a small to medium size company. It offers easy and flexible customization that doesn't require third party consultants to implement.
Minimal.
Lessons for Success
Planning the integration and expansion of new modules is advantageous.
We created Quality Processes to track living files such as the Design History File, Device Master Record, Risk Management File, and Usability/Human Factors Engineering File. These files can then be linked to controlled procedures, design documents, test reports, Nonconformance Reporting, CAPA, Audit Observations, and Complaint Investigations.
Learn the features and build a document/system infrastructure plan before creating any items or processes in Arena.
Evaluating Arena and Competitors
Yes - We replaced Q-Pulse because it wasn't validated and lacked the wider range of functions and level of customization available in Arena.
No changes needed.
Arena Support
| Pros | Cons |
|---|---|
None | None |
I've used Arena for 6+ years and could probably count the number of service requests on one hand. Nothing good or bad comes to mind.
Using Arena
| Pros | Cons |
|---|---|
Like to use Relatively simple Easy to use Technical support not required Well integrated Consistent Quick to learn Convenient Feel confident using | Lots to learn |
- Document Control
- Quality Processes
- Supplier Management
- Approvals of Quality Module "Release 1" (I initiated a few that still linger)