Essential Tool for Document Control, Engineering Change Management, and Regulatory Compliance Improvement
July 16, 2024
Essential Tool for Document Control, Engineering Change Management, and Regulatory Compliance Improvement
Score 9 out of 10
Vetted Review
Verified User
Overall Satisfaction with Arena PLM and QMS
My organization uses Arena PLM and QMS for quality management system documentation control daily. Being in a medical device company this control is crucial to maintain traceability of documentation and proper retention of documentation for regulatory compliance. We use it to track engineering/quality changes, supplier control, and second sourcing, as well as to track non-conformities (NC) and corrective and preventive actions (CAPA). Soon we will use it for the control of non-conforming material and the appropriate follow-up with suppliers to avoid reoccurrences.
Pros
- Excellent control of documentation and revision changes.
- Ease of use in the user-friendly interface.
- Easy to delegate the signature in the absence of colleagues due to vacations or disabilities.
Cons
- Due to the number of options, training must be thorough.
- Filter search could be improved.
- Linking with other applications and interfaces.
- Regulatory compliance
- Reduced engineering and quality change cycle time
- Improved communication with implementation tasks
- Cloud Solutions
- Scalability
- Ease of Use
Ease of use is crucial in the day-to-day operations of any corporation. It is needed as a reliable solution for tracking day-to-day issues, searching for documents, updating documents and ensuring audit readiness and regulatory compliance. It is undoubtedly an indispensable tool that most of the departments use on a daily basis.
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?
I wasn't involved with the selection/purchase process
Did implementation of Arena PLM and QMS go as expected?
Yes
Would you buy Arena PLM and QMS again?
Yes
Comments
Please log in to join the conversation