Compliance and Regulatory process during AMS of Life Science applications

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi all,

I would like to know the Regulatory and compliance processes and procedures to be followed during the AMS of Life Science applications.

We have Successfully implemented the ERP application in a Medical Device manufacturing company and we are propsing the AMS for the same. It would be appriciated if anyone share thier experiences and thoughts to meet the Regulatory and Compliance requirements during AMS process.

Thanks.