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.
The GitLab Duo Agent Platform is changing the game for software developers by providing a place for AI agents to help with planning, coding, security analysis, and analytics. While help from AI sounds great, ROI often falls short due to teams misusing it or failing to...
Introduction Michael Roberts: Hello, everyone, and welcome back to another SPK & Associates Vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing for SPK & Associates, and today we're going to talk about a topic that's really cool:...
Key Takeaways Gut-feel prioritization does not scale. A consistent scoring framework helps teams make backlog decisions based on business value, effort, urgency, and risk instead of whoever asks the loudest. Foxly brings prioritization directly into Jira. Teams can...
Key Takeaways AI needs lifecycle context to deliver real value: Standalone AI tools often struggle because they cannot see how requirements, designs, code, tests, and quality data connect across the product lifecycle. The digital thread provides the missing context:...