The kinds of data that will need to be measured and analyzed in process validation fall into two basic categories: attributes and variables. A thing can have many attributes — traffic lights have three colors, for instance — but in quality assurance, says Dan O’Leary, president of Ombu Enterprises, the focus tends to be on two attributes, conforming and nonconforming.
To View This Article:
Subscribe To Device Daily Bulletin Premium
Device Daily Bulletin Premium Subscription
Upgrade to Device Daily Bulletin Premium to get all the articles in the free publication PLUS more in-depth stories on regulatory and industry developments, FDA inspection and enforcement activities and analysis of market trends. It makes sense of everything successful devicemakers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay compliant and thrive. And it’s combined with timely content from FDAnews management reports and webinars. Learn more