Item: Arena PLM and QMS
Rating: 8
Author: Tish Rowley

Overall Satisfaction with Arena

Use Cases and Deployment Scope

We use Arena to document our parts & processes, primarily in the engineering area. We are including more departments to encompass the design, validation and production functions, as well. We have recently implemented forms in the Quality module to track our design/validation processes. Historically, this has just been a parts & process repository for the engineering team.

Pros and Cons

Pros

We can now link our quality process results to parts. This helps when looking at revisions and releases.
Arena is flexible in allowing creation of items and naming conventions.
The quality module, while still a little clumsy, provides a good place for creation of forms and procedures.

Cons

Arena is not the most intuitive, especially where users are promoting a request - the option to "raise an issue" is not easily seen or discerned, causing users to simply comment when they really mean to raise an issue. This process is a little clumsy.
Adding a document to a signed-off quality process is either clumsy (need to re-validate or do proxy validation after re-opening the process), or sneaky, by going in and replacing the document associated with the file number. Sometimes, we just need to add a forgotten document.

Return on Investment

I cannot address these issues. Arena has not been used extensively enough by the entire organization to measure this.

Key Differentiators

Not my decision. This tool was being used when I got here. But when we were evaluating Arena in my previous company, the nature of medical device manufacturing and the needs for regulatory compliance were not met by Arena. The new module may make a big difference for the med device companies evaluating Arena going forward.

Arena Implementation

I was not part of this experience. Arena has been in use at my current company for many years. The revision roll-out webinars, however, have been very useful, as are the training videos.

Alternatives Considered

Again, I did not select Arena where I work, and we passed on it where I worked previously because it did not meet the requirements for regulatory compliance.

Likelihood to Recommend

The new requirements module seems to be very much like the MasterControl card system, but it does add more functionality that is needed for a regulated environment. I'd need to actually use to to determine if it would fill in the "holes" which would have prevented it from being well-suited to a regulated industry where design controls, traceability and compliance to requirements are critical to production records.

Tracking of production lots does not seem to be easily done in the existing modules.

Comments

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Scott Reedy
(Vendor Representative) commented 6 years ago
Thanks Tish for taking the time to provide your review. It's good to hear the quality module is helping to track design and validation processes. I will pass along your feedback to our product team regarding where we can improve our solution.

Arena - a pretty good tool.