fbpx
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

Open Source Due Diligence Checklist

Open Source Due Diligence Checklist

Proper open-source software management is vital to ensuring issue-free code. This checklist will explore the practices your team must take to prevent coding issues. What You Will Learn In this eBook, you will discover the best questions to ask and warning signs to...

Related Resources

Open Source Due Diligence Checklist

Open Source Due Diligence Checklist

Proper open-source software management is vital to ensuring issue-free code. This checklist will explore the practices your team must take to prevent coding issues. What You Will Learn In this eBook, you will discover the best questions to ask and warning signs to...

PLM vs. PDM: Understanding the Key Differences for Engineering Teams

PLM vs. PDM: Understanding the Key Differences for Engineering Teams

Accelerating product development, improving product quality, and enhancing collaboration are all main priorities for designers and manufacturers. Achieving these goals requires the proper digital solutions for managing product data and processes. Product Lifecycle...