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FAQ: Are medical device packaging suppliers required to have electronic documentation systems that are compliant with FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures) requirements?
 

&A: No. However, there are advantages to seeking a supplier that utilizes electronic records that are compliant with 21 CFR Part 11; such a supplier can track and respond to corrective action needs much more quickly.

 

FAQ&A group

Lora Keena
Vice President of QA/RA

 

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