fbpx
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

Model-Based Definition Capabilities in Creo

Model-Based Definition Capabilities in Creo

Model-based definition (MBD) is a design approach that revolves around creating, organizing, and managing a 3D Model. Explore how PTC Creo utilizes MBD to help you achieve an efficient design.  What You Will Learn In this eBook,...

Related Resources

Optimizing Solidworks PDM Implementation

Optimizing Solidworks PDM Implementation

When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way.  Rather than fixing the issues that would inevitably keep occurring with their...

Transforming Product Development with Configuration Management

Transforming Product Development with Configuration Management

When developing products, there are many components to keep track of such as parts, data, and configurations.  Keeping up with every minor alteration to a product can be difficult, but using a PLM system like PTC Windchill can help you stay organized.  Configuration...