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.
Software-defined and electric vehicles are only increasing as automotive technology advances. As these features grow, automakers must adapt. Manufacturing a car is not the same as it was years ago. This eBook explores how AI can be used in the automotive development...
Key Takeaways Governance must come before scale: AI agents can access data and take actions, meaning clear rules around what they can see and do must be established before widespread deployment. Follow the principle of least privilege: Agents should only receive the...
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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...