Arena PLM and QMS — a near-perfect choice for Medical Device manufacturers
August 25, 2023
Arena PLM and QMS — a near-perfect choice for Medical Device manufacturers
Score 10 out of 10
Vetted Review
Verified User
Overall Satisfaction with Arena PLM and QMS
As a Medical Device manufacturer, [...] is subject to various FDA Regulations and ISO Standards in order to maintain the Certifications necessary to market our medical devices. The PLM module allows [...] to maintain compliance with the Design Controls and Production and Process Controls requirements; the Arena PLM and QMS module supports the [...] Quality Management System (AQMS) which is regularly audited or inspected by the FDA and the Notified Body, the British Standards Institute.
Since the implementation of the Arena PLM and QMS, [...] has realized an 80% reduction in observations or findings during these audits, as well as a 200% increase in efficiency and productively of our quality processes; e.g., Complaint Handling, Non-Conformances (NC), and Corrective Action, Preventive Action (CAPA).
Using Arena PLM and QMS to construct Quality Processes where information is entered into online forms in Arena PLM and QMS, we have reduced the amount of paperwork and MS Word files by 50%, and dramatically decreased errors and omissions.
Since the implementation of the Arena PLM and QMS, [...] has realized an 80% reduction in observations or findings during these audits, as well as a 200% increase in efficiency and productively of our quality processes; e.g., Complaint Handling, Non-Conformances (NC), and Corrective Action, Preventive Action (CAPA).
Using Arena PLM and QMS to construct Quality Processes where information is entered into online forms in Arena PLM and QMS, we have reduced the amount of paperwork and MS Word files by 50%, and dramatically decreased errors and omissions.
Pros
- Ability to create custom Quality Processes
- Ability to create custom reports
- Powerful Analytics (with the Analytics module)
- Maintenance of the Device History Record (DHR)
- Maintenance of the Approved Supplier List (ASL)
- Facilitation of Training Programs
Cons
- In my opinion, the Help Pages clearly do not realize that a picture is worth a 1,000 words; need illustrations and screenshots!
- I think the 'Save' button when editing Quality Processes needs to "float" on the active page, not lurking at the bottom.
- In my experience, the Arena PLM and QMS Training programs need to be revamped to include "real-world" examples and working through examples, not simply reading through a training manual.
- Arena PLM and QMS has allowed [...] to efficiently respond to Design Changes and process them effectively.
- Arena PLM and QMS has completely automated our CAPA process, removing all paperwork and 99% of other electronic files.
- Arena PLM and QMS has allowed our Contract Manufacturing Organizations (CMO) to upload current manufacturing data; this puts [...]'s finger on the pulse of a CMO thousands of miles away. No more surprises.
- Scalability
- Integration with Other Systems
- Ease of Use
Integration with other systems. Currently, Arena PLM and QMS is integrated with Salesforce (via FlowEQ), Solidworks (via CADTALK), Rimsys (natively); this ties nearly all of our PLM and QMS functions together.
For us, deployment of the Arena PLM and QMS was lightning fast. The implementation team, and our Arena Solutions Architect are the best I have encountered in my 43 years in BioTech.
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
Using Arena PLM and QMS
We use Arena PLM and QMS for compliance with all medical device regulations, including, but not limited to, FDA, MDSAP, ISO, ITAR, RoHS, REACH, WEEE, RDC, PMDA, etc.
We have expanded Arena PLM and QMS to maintain our Bill of Materials created in Solidworks, integrated our regulatory documents into Rimsys (our Regulatory Information Management) system, and are currently implementing Design, Document, Manufacturing, Regulatory, and Clinical Change Control processes in Arena PLM and QMS.
In my opinion, Arena PLM and QMS is the Ringmaster of all PLM and QMS processes.
Excellent. In 43 years, I have never once encountered a customer success team who actually cared about the customer as much as the folks at Arena do. It hasn't been even close.
Comments
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