spk-logo-white-text-short2
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

Related Resources

10 Key Steps to Successful Software Development Using Jira

10 Key Steps to Successful Software Development Using Jira

Jira has become a cornerstone tool for software development teams, providing robust project management capabilities, issue tracking, and seamless collaboration.  However, maximizing its potential requires a structured approach tailored to your team’s goals and...

Unlock a Complete Toolchain

Unlock a Complete Toolchain

Software development teams can be particular about the tools they use.  Being picky can often lead to challenges such as tool sprawl, knowledge silos, and overall inefficiencies.  These bumps in the road slow down their ability to successfully deliver applications to...