Reading through some recent U.S. FDA Warning Letters to pharma
manufacturers concerning data integrity, I came across a new one
regarding a Chromatography Data System (CDS). There were a couple of
very powerful sentences in the letter that companies ...
"You have all these audit trails, which provide great information about
your testing, but none of your procedures tell you to review those audit
trails. I'll expect to see that next time I'm here."Those were the words
from an FDA inspector toward the...
Hi Angelo,Yes! Thermo Scientific Chromeleon CDS is capable of
controlling the TSQ Quantiva as well as processing/reporting the data
acquired while using it. Chromeleon CDS has been designed with
compliance in mind, so it will be perfect for your GLP ...