Setra Blog


July 15, 2022

FDA 21 CFR Part 11, Predicate Rules and Environmental Monitoring

 

Continue Reading →

May 05, 2021

Environmental Monitoring Best Practices for Data Trending

Analyzing trends in data is an important aspect of environmental monitoring for facilities.

Continue Reading →

April 06, 2021

21 CFR Part 11 Compliance

Cleanrooms for medical device and pharmaceutical manufacturing are highly regulated spaces and there are numerous standards that need to be considered. When it comes to how data is handled in regulated cleanroom environments, the United States FDA issued 21 CFR Part 11 guidance that should be followed closely.

Continue Reading →