Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems.
You are now expected to trend your quality data.
In fact, the FDA wants you to maintain a 24/7 state of control by proactively monitoring your quality systems.
And compliance isn’t optional, despite the fact that your information sits isolated in “data silos” like complaints and OOS — making your task of identifying trends nearly impossible.
How serious are they? Consider just three recent examples (with emphasis on trend added):
Your company may not have received such a citation ... yet. But every FDA inspection includes scrutiny of quality measurement and trending mechanisms. The time to beef up your procedures is now. Announcing the publication of Quality Data Trending: Requirements and Best Practices for Devicemakers.
This all-new special report from FDAnews shines the spotlight on this essential, but often neglected, area of quality control. In plain English, it:
Concerned about whether your data analysis methods will pass FDA muster? Stop worrying — and do something about it. Order your copy of Quality Data Trending now!
1. Overview & Requirements
2. Warning Letter Analysis
3. Quality Data Sources
4. Trending Methodologies
5. Procedure Requirements
Quality Data Trending: Requirements and Best Practices for Devicemakers is available in print and PDF format for $377 each. Order your copy.
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