Does the measurements taken on the Software of the AP3900 meet the requirements of data integrity as per 21 CFR part 11?

Document ID

Document ID TE8356

Version

Version 2.0

Status

Status Published

Published Date

Published Date 03/20/2018
Question
Does the measurements taken on the Software of the AP3900 meet the requirements of data integrity as per 21 CFR part 11?
Summary
data integrity AP3900
Answer
INTERNAL/AUTHORIZED SERVICE PROVIDER INFORMATION DO NOT FORWARD TO CUSTOMER

The measurements taken on the Software of the AP3900 meets the requirements  definitely not!

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