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QUALITY TALK – November 2021

Arena Solutions
 
 
SaaS PLM Transforms NPI

4 Ways SaaS PLM Transforms New Product Introduction

#webcast #plm #supply chain

Today more and more manufacturers are reimagining new product development processes by leveraging digital technologies to make better business decisions and accelerate product launches.

Join this upcoming virtual event with our EU team to learn how cloud-based PLM and QMS technology helps companies:

  • Accelerate global collaboration
  • Deliver innovative products to market faster
  • Ensure quality and regulatory compliance
  • Improve operational efficiency and cost control

Event Time: Thursday, November 18 | 1 pm GMT, 2 pm CET

*If you are unable to attend the event, still register to receive the event recording.

QMS Tip of the Month

QMS Tip of the Month: Simplify Audits With a Complete DHF

#tipsandtricks #qms

Need to get your DHF to an auditor ASAP? With Arena QMS, you can easily export the DHF into convenient packages. The Quality Export feature allows you to quickly generate a zip file and folder directory that contains all the files associated with the Quality Process in XLS or PDF format.

Tip: You can create quality export settings that can be used on all future exports.

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5 Essential Elements

5 Essential Elements of a CAPA System

#bestpractices #compliance #medicaldevices

Establishing a compliant CAPA process can create obstacles for many medical device companies, especially when working with manual systems. In 2020, the FDA issued 197 citations (i.e., Form 483s) to companies as a result of CAPA-related issues. Learn how a product-centric QMS with connected CAPA capabilities can help you avoid FDA 483s and other compliance risks.

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Managing the DMR

Managing the DMR to Comply With FDA Regulations

#bestpractices #compliance #medicaldevices

Managing changes to the device master record (DMR) can be challenging if you are working with spreadsheets and other manual systems. Ultimately, you end up with data errors and a lack of traceability. Learn how automated solutions like Arena QMS can help you document and communicate changes to the DMR more effectively and achieve FDA compliance with confidence.

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