eInfotree Excel Plug-In 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Excel Module
Compliance

eInfotree Excel Module
Implementation

Client Responsibilities

11.10(e)

Record changes shall not obscure previously recorded information.

The audit trail records cell values before and after changes are made thus protecting previously recorded information. Deleted or inactive User IDs can be recalled at any time thus restoring previously recorded information.
 

11.10(e)

Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

The audit trail is stored internally in the Excel file and hence is automatically retained for as long as the workbook itself, and is easily available for agency review and copying using Excel.
 

11.10(f)

Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

eInfotree Excel Module is compatible with any custom developed functions to enforce permitting sequencing of steps and events, as appropriate.

If required, these system checks can be built using custom Excel functions. CSI can provide assistance if required.

11.10(g)

Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
 

eInfotree Excel Module contains all the specified authority checks. Refer to Section 11.10(d).

11.10(h)

Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

eInfotree Excel Module is compatible with any custom developed functions to enforce device checks to determine the validity of the source of data input or operational instruction, as appropriate.

If required, device checks can be built using custom Excel functions. CSI can provide assistance if required.