Part 11

The emphasis of Part 11 is to assure that only authorized personnel enter data, review the data, and/or change the data. All changes to the data needs to have an explanation, just as error corrections on paper require a note explaining the reason for the change. This notation is referred to as the audit trail. Care must be taken in the selection of software that includes a secure audit trail if electronic records are to be used.

Subparts B and C (of 21 CFR Part 11) represent the main body of the requirements. Only an overview of the requirements will be presented here; further study will be required to fully understand this section of the CFR.

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Mar 4, 2017 | Posted by in PHARMACY | Comments Off on 11

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