Hello All,
I have recently been tasked to obtain information surround governing regulations applicable to my corporations artwork management system.
Our system is validated for and compliant with U.S. Title 21 CFR Part 11 - electronic signatures. To my knowledge, this is the only FDA regulation the system itself needs to adhere to.
My question is, are there any other government mandated regulations/requirements surrounding pharmaceutical artwork approvals (that I am sure we adhere to) that I am simply not aware of?
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Noel Ketchi
Associate Director, Artwork and Pack Design Processes
Alkermes, Inc
Waltham MA
(781) 392-4623
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