spk-logo-tm-2023
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends

Introduction

Does your company properly manage Design Outputs?  The FDA routinely examines this area as part of an audit process.   In this article we review what it means to have your design outputs in order as well as present some recent warning letter examples.

We invite you to download our paper on this topic.

Learn more about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage.

Latest White Papers

Is Your CAD System Letting You Down?

Is Your CAD System Letting You Down?

When you outgrow your CAD system, it is time to upgrade to PTC Creo. Dive into this downloadable eBook to explore how one of the best CAD solutions on the market can change your product design for the better.What You Will Learn Discover how Creo users benefit from the...

Related Resources

The Journey of Software Integration

The Journey of Software Integration

When sharing multiple software across companies, it is important to ensure secure and seamless data delivery. Discover how Exalate helps integrate tools to enable a successful software integration journey.What You Will Learn In this eBook, you will explore: What a...

Why Teams Are Replacing HP ALM with Jira

Why Teams Are Replacing HP ALM with Jira

For years, HP Application Lifecycle Management (formerly known as Quality Center) was a go-to solution for requirements, testing, and defect management. However, with product transitions and support timelines expiring, many organizations are reevaluating their...