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Welcome To ExcelSafe

This document summarizes the key features of ExcelSafe, a software tool that provides spreadsheet security and compliance with regulations like 21 CFR 11. It allows features like requiring reasons for changes, recording audit trails of all edits, restricting cell selection and editing, adding electronic signatures to lock down sheets, and more. Administrators can also remediate cell formats and record defined cell ranges to the audit trail. The tool is designed to make Excel sheets secure and compliant for regulated environments like clinical trials.

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sheeron20
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862 views

Welcome To ExcelSafe

This document summarizes the key features of ExcelSafe, a software tool that provides spreadsheet security and compliance with regulations like 21 CFR 11. It allows features like requiring reasons for changes, recording audit trails of all edits, restricting cell selection and editing, adding electronic signatures to lock down sheets, and more. Administrators can also remediate cell formats and record defined cell ranges to the audit trail. The tool is designed to make Excel sheets secure and compliant for regulated environments like clinical trials.

Uploaded by

sheeron20
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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ExcelSafe

Spreadsheet Security Made Simple


Welcome to Ofni Systems' ExcelSafe. ExcelSafe provides MS Excel spreadsheets with the technological tools to be compliant with 21 CFR 11 and other regulatory rules for electronic data.

This spreadsheet will introduce you to the features of ExcelSafe, including the technological tools to make a spreadsheet compliant with 21 CFR 11.

1 5

eets with the or electronic data.

echnological tools to

Navigate to the Active Sheet Utilities tab in ExcelSafe. Verify that the Reason for Change field is set to Required. ExcelSafe can be configured to require users to justify changes to data. 1. Modify the data in Cell B7. When prompted for a reason for change, enter "Training". This is Cell B7. Edit me. In ExcelSafe, click Audit Trail. Notice that the most recent line includes the sheet name (Reason_for_Change), the Cell ($B$7), the edit type (changed), the original value ("This is Cell B7, edit me."), the new value, your user ID, todays date and the reason for change (Training). Users are not required to provide a Reason for Change when adding data to a spreadsheet. 1. Add data to Cell B15. Add Data here. In ExcelSafe, click Audit Trail. Notice that the most recent line includes the sheet name (Reason_for_Change), the Cell ($B$15), the edit type (Added), the new value, your user ID and todays date. Since this was new data, no original value or reason for change was recorded. Users can enter a default Reason for Change. Change the value in the Reason for Change field to "Demonstration". 1. Modify the data in Cell B23. This is Cell B23, edit me.

In ExcelSafe, click Audit Trail. Notice that the most recent line includes the sheet name (Reason_for_Change), the Cell ($B$23), the edit type (changed), the original value ("This is Cell B23, edit me."), the new value, your user ID, todays date and the reason for change (Demonstration). Users can also enter NULL for a reason for change. This leaves the Reason field NULL on the audit trail.

raining".

et name ue ("This is Cell B7, (Training). to a spreadsheet.

et name your user ID and todays rded.

et name alue ("This is Cell B23, (Demonstration).

eld NULL on the audit

Navigate to the Active Sheet Utilities tab in ExcelSafe. Verify that the Allow MultiCell Selection checkbox is unchecked. ExcelSafe can be configured to restrict users from manipulating a single cell. Drag Cell B8 to Cell F8. Single From here

To here

Attempt to drag merged cell B14:B15 to F14:F15.

Multi Attempt to drag from here

To here

Navigate to the Active Sheet Utilities tab in ExcelSafe. Verify that the Allow MultiCell Selection checkbox is checked. ExcelSafe can be configured to allow users to manipulating multiple cells. Drag Cell B8 to Cell F8. Single From here

To here

Attempt to drag merged cell B14:B15 to F14:F15.

Multi Attempt to drag from here

To here

s.

Adding Electronic Signatures Verify that you can edit all of the cells below. Value A Value B 1 5 2 4 3 3 Sum 6 6 6 First Signature: Second Signature:

1. Select Cell H5. 2. Click on the Sign Active Sheet field. 3. Enter your user password. 4. When asked to confirm the user password, click Yes. Verify that you can no longer edit data on the spreadsheet. 5. Select Cell H6. 6. Enter your password, and confirm the decision to add the second signature. An electronic signature cannot obscure spreadsheet data. 1. Select any cell with data. 2. Click the Sign Active Sheet field, and enter your password. Removing Electronic Signatures 1. Click Remove Electronic Signatures. Verify that you can edit data on the spreadsheet.

Cell Remediation Consider the following formula: four data points, organized into 2 rows and 2 columns. Take the sum of each row and column, and find the different in the product of the two sums. Column A Column B 1 2 4 3 5 5 Horizontal Sum 3 7 4

Row 1 Row 2 Vertical Sum

1. On the Active Sheet Utility tab, click Remediate Formats. Notice that the data entry cells (C6:D7) are colored yellow, and the formula cells (D9:E9, F6:F7 and F9) are colored green. Also notice that all cells not identified as Data Entry cannot be edited, but data entry cells can be edited. Remediation is not necessary, but provides a method of increasing useabilty of spreadsheets which increasing spreadsheet protection. Remediation is typically restricted to system administrators.

olumns. Take the sum

s (D9:E9, F6:F7 and not be edited, but data

spreadsheets which

Recording Cell Range ExcelSafe can record a range of cells to the audit trail. 1. Select the cell range D7:D10. Value A Value B 1 5 2 3 3 3 Sum 6 5 6

2. With the range selected, enter "Record_Test" in the Name Box. 3. Edit values in the data entry cells (B7:C9). 4. Close the spreadsheet, and view the audit trail. Note that the current value of the calculated fields were recorded to the audit trail. Typically, ExcelSafe does not record calculated values (only data entry values and the formula). Recorded ranges provide a method of copying ranges of cells to the audit trail.

f the calculated fields

and the formula).

ExcelSafe Audit Trail More Info Created On / By: 6/24/2008 8:42:21 AM by Ofni Systems Last Edited On / By: 11/10/2008 12:26:38 PM by Ty Audit Trail Produced On / By: 1/26/2012 8:45:12 AM by ESAdmin

Sheet Cell Ofni Systems ExcelSafe Demo1 Opened ExcelSafe Audit Trail N/A

Edit Type Default Added

Old Value

New Value ExcelSafe Audit Trail C:\ExcelSafe\Spreads heets\Welcome to ExcelSafe.xls

Welcome to ExcelSafe.xlsClosed Welcome to ExcelSafe.xlsDate Last Saved Introduction $D$9 Introduction $D$8 Introduction $D$9 ExcelSafe Audit Trail Updated Data Welcome to ExcelSafe.xlsDate Last Saved

Changed Changed Added Added Changed Default Changed

Ofni Systems ExcelSafe Demo1

7/31/2008 6:42:40 AM 7/31/2008 5:42:40 AM 2 1 2 5 11/10/2008 3:26:38 PM 11/10/2008 12:26:38 PM C:\ExcelSafe\Spreads heets\Welcome to ExcelSafe.xls

Welcome to ExcelSafe.xlsClosed

Added

By UserID Ofni Systems Ofni Systems

Date/Time Reason for Change 7/31/08 6:41:46 AM 7/31/08 6:42:39 AM

Ofni Systems Esadmin Esadmin Esadmin Esadmin Esadmin Esadmin

7/31/08 6:42:39 AM 11/10/08 3:25:38 PM Updated template 11/10/08 3:25:47 PM 11/10/08 3:25:47 PM 11/10/08 3:25:58 PM edit test 11/10/08 3:26:33 PM 1/26/12 8:32:10 AM Investigate

Esadmin

1/26/12 8:45:11 AM

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