Introduction Maintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483...

Connecting Products and Projects Helps Streamline Regulatory Compliance This is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and keep up with engineering changes. Now we will discuss tips on how to...

Meeting Product Requirements and Streamlining Engineering Changes Throughout this series, we have been exploring how manufacturers can streamline new product development and new product introduction (NPDI) by connecting the entire new product team with a centralized product record for a single source of truth. During the first installment, we covered the challenges product companies face in...