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5 Tips to Pass Your FDA or ISO Audit with Confidence

An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device ma...

Training Record Management Software: The First 3 Steps to Automation

Training record management is a major element of quality management, compliance, and regulatory practices as well as employee ...

Is Product-Centric QMS Right for Your Company?

Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture ...

The 5 Essential Elements of a CAPA System

Using a compliant quality management system (QMS) with a CAPA subsystem, your company will be ahead of the 465 companies with CAPA-related FDA 483s. ...

Moving From Paper to Electronic Changes and Approvals

It is possible to achieve FDA 21 CFR Part 11 compliance while implementing an electronic change management system. This article outlines five key ...

Managing The Device Master Record (DMR) to Comply with 21 CFR Part 11 and Part 820

The device master record (DMR) is an all-encompassing collection of documents and records that must be controlled per FDA 21 CFR Part 820. ...

Medical Device Development: From Specification through Validation

Medical device manufacturers are heavily regulated organizations and rightly so. Manufacturing a potentially lifesaving device ...

4 Challenges Document Management Software Solves

Document management software helps organizations manage documents electronically. The software enables users to ...