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John O’Neill
Moderator
Post count: 33

Hi Jeanine,
I’m not an expert in this area, but in a lot of years of experience, I’ve not encountered a situation where tightening specs translated into an OOS scenario. Good justification and documentation in close coordination with QA and Regulatory colleagues (with equal application to RT and ACC conditions) should keep you in good standing with our friends at FDA. Comments by others with more experience in this situation are welcome.
John O’Neill