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QUALITY AND COMPLIANCE

What Are the Key Elements of a Quality Management System (QMS)?

Having an effective quality management system (QMS) in place for life sciences companies is critical to help organizations reach their product develop...

Validation for Cloud Software

When evaluating software vendors, be sure to prioritize validation. Multi-tenant cloud vendors give you a head start by doing IQ and OQ for you. Cloud...

How to Classify Your Medical Device for FDA Approval

The FDA classification process can be a daunting task. Where do you start and how do you know that your medical device is assigned the proper classifi...

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...

Streamline New Product Introduction (NPI)

New product introduction (NPI) and new product development (NPD) are often referred to in the same way or confused by many. ...

Managing Your BOM: Spreadsheets vs. Product Lifecycle Management

Manufacturers rely on the item, assembly, documents, and related product record information that is included in a bill of materials (BOM) ...

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 ...

Selecting a PLM Solution for Defense Product Development

Read how secure cloud technology meets commercial and defense demands. We help drive secure product development in the cloud to meet ITAR/EAR. ...

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. ...

5 Steps to Scale Your Business When Your Competition Stumbles

What you know about your business today will help you get ahead, but what you don’t know can cost you time, money, and market share. ...

3 Strategic Sourcing Lessons from one OEM’s $7B Supply Chain

Strategic sourcing is a primary focus when running a $7B global supply chain. An original equipment manufacturer (OEM) that outsources relies heavily ...

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 ...

10 Key Challenges & Keys to Success for Outsourcing Manufacturing

We identify top outsourcing issues and offer insights on how to address them to help you establish long-term success in outsourcing manufacturing. ...

4 Challenges Document Management Software Solves

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