Validating our software—we make it easy
The Validation Maintenance Service provides subscribed Arena customers with a complete Software Validation File, including completed Impact Analyses, IQ and OQ protocols, and additional compliance certification for the Arena PLM software. This documentation can be used directly by our customers to support the success of their own regulatory audits.
Because Arena PLM is delivered as a subscription based, single instance, on demand service, and run from an Arena managed hardware installation with full back up and disaster recovery handling, there is no need for customers to validate their own individual instance of the software. And because numerous medical device companies utilize the Arena PLM software to provide structure and storage for DMR, DHF and QMS documents, Arena is able to validate the software against a well defined set of intended uses. Therefore, Arena is able to provide customers with the results of Arena’s internal software validation for use as their own evidence of system compliance, saving our customers the time and expense associated with completing these efforts themselves.
1.866.937.1438 | 
The Validation Maintenance Service includes:
- Upgrade Notification for all major releases emailed directly to subscribed VMS customers.
- Complete Software Validation File with every major release, including an Impact Analysis of the new release, and Updated and Executed IQ and OQ Protocols.
- Customer Audits—the validation team at Arena welcomes VMS customers for half day audits of the Arena validation activities, facilities, security architecture and quality management system.
- Validation Templates for your Quality System to help you get the validation process jump started.
Talk to Arena Solutions today about subscribing to the Validation Maintenance Service… sales@arenasolutions.com.
