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

Introducing Atlassian’s Service Collection

Introducing Atlassian’s Service Collection

Are you looking for new tools that empower your teams to deliver exceptional service experiences? Atlassian’s Service Collection ensures great service for both employees and customers. What You Will Learn In the following eBook, you will discover: The tools and...

Related Resources

5 Ways to Reduce Engineering Cycle Time Without Adding Headcount

5 Ways to Reduce Engineering Cycle Time Without Adding Headcount

Key takeaways Faster engineering does not always require more headcount: Disconnected systems, manual handoffs, rework, and poor visibility often create more delays than a lack of engineering capacity. A digital thread can eliminate major sources of wasted time:...

Why Late-Stage Changes Are Killing Your Time to Market

Why Late-Stage Changes Are Killing Your Time to Market

Key Takeaways Late-stage changes get expensive fast: The farther a problem travels through design, testing, and manufacturing, the more time, cost, and rework it creates. Disconnected systems and weak traceability are major causes: When requirements, design, software,...

What CIOs Get Wrong About PLM and Digital Thread Strategy

What CIOs Get Wrong About PLM and Digital Thread Strategy

PLM and Digital Strategy for CIOs Hello, everyone, and welcome back to another SPK and Associates vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing here at SPK and Associates. Today, we're tackling a topic that comes up consistently in...