SPREADSHEET VALIDATION 101:

CREATE AND VALIDATE FDA-COMPLIANT

MS EXCEL SPREADSHEETS

R AUL S OTO, MS C, CQ E
IVT A PRIL 2015 P HILADELPHIA

ABOUT THE AUTHOR

20+ years of experience in the medical devices, pharmaceutical,
biotechnology, and consumer electronic industries
MS Biotechnology, emphasis in Biomedical Engineering
BS Mechanical Engineering
ASQ Certified Quality Engineer (CQE)
I have led validation / qualification efforts in multiple scenarios:

High-speed, high-volume manufacturing and packaging equipment

Laboratory : information systems and equipment / instruments
Enterprise resource planning applications (i.e. SAP)
IT network infrastructure
Software applications
Product improvements, material changes, vendor changes

Contact information:
Raul Soto

rasove_21@yahoo.com
2

TABLE OF CONTENTS
1. REGULATORY PERSPECTIVE
2. SPREADSHEET VALIDATION
3. BUILDING A COMPLIANT SPREADSHEET
4. HANDS-ON EXERCISES

SCOPE
SPREADSHEET
Microsoft Excel file that may contain:
mathematical calculations
Statistical analysis
Graphing

Outside our scope:

Macros or custom code
Database lookups
4

PART 1: REGULATORY
PERSPECTIVE
REGULATIONS GOVERNING SPREADSHEETS

WHICH SPREADSHEETS NEED TO BE

VALIDATED?
If the spreadsheet supports any activity governed by
applicable regulations, it should be validated

FDA 483S AND WARNING LETTERS

Companies have been cited by FDA for not
validating spreadsheets used for:

Inprocess analytical calculations

Finished Product analytical calculations
Tracking and trending quality metrics
Databases / list

FDA 483
Pharmaceuticals (Eli Lilly):

FDA WARNING LETTERS

Pharmaceuticals (Cardinal Health):

http://www.contractormisconduct.org/ass/contractors/18/cases/305/221/f
da-warning-letter.pdf

FDA WARNING LETTERS

Pharmaceuticals (Aarti Drug Limited):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm
369409.htm

FDA WARNING LETTERS

Biologics (National Genetics Institute):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/u
cm075766.htm

FDA WARNING LETTERS

Medical Devices (Aubrey Inc.):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm2
56498.htm
12

FDA WARNING LETTERS

Medical Devices (B. Braun Medical Ltd):

http://www.ofnisystems.com/media/g3667d.pdf

FDA WARNING LETTERS

Medical Devices (Eldon Biologicals A/S):

http://www.ofnisystems.com/Resources/Warning_Letters/g4452d.pdf

FDA WARNING LETTERS

Medical Devices (EP Medsystems):

http://www.ofnisystems.com/media/g1483d.pdf

MEDICAL DEVICES
21 CFR 820.70(i): Automated processes
When computers or automated data processing
systems are used as part of production or the
quality system, the manufacturer shall validate
computer software for its intended use according
to an established protocol.
All software changes shall be validated before
approval and issuance.
These validation activities and results shall be
documented.
16

MEDICAL DEVICES
Lets take this apart:
Applies to computer / data processing systems used for
production or quality
The manufacturer is responsible for validation

Validation must be for the intended use(s)

Must have an established protocol
Changes must be validated before implemented
Document all validation activities and results

17

MEDICAL DEVICES
Section 6.0
Many other commercial software
applications, such as word processors,
spreadsheets, databases, and
flowcharting software are used to
implement the quality system. All of
these applications are subject to the
requirement for software validation, but
the validation approach used for each
application can vary widely.

18

MEDICAL DEVICES
Section 6.1
Numerous commercial software
applications may be used as part of the
quality system (e.g., a spreadsheet or
statistical package used for quality system
calculations, a graphics package used for
trend analysis, or a commercial database
used for recording device history records or
for complaint management). The extent of
validation evidence needed for such
software depends on the device
manufacturer's documented intended use of
that software.

19

PHARMACEUTICALS
21 CFR 211.165(e): Testing and Release
for Distribution
(e) The accuracy, sensitivity, specificity, and
reproducibility of test methods employed by the
firm shall be established and documented. Such
validation and documentation may be
accomplished in accordance with 211.194(a)(2).

20

BIOLOGICS
21 CFR 606.140: Laboratory Controls
Laboratory control procedures shall include:
(a) The establishment of scientifically sound and appropriate
specifications, standards and test procedures to assure that
blood and blood components are safe, pure, potent and
effective.
(b) Adequate provisions for monitoring the reliability,
accuracy, precision and performance of laboratory test
procedures and instruments.
(c) Adequate identification and handling of all test samples so
that they are accurately related to the specific unit of product
being tested, or to its donor, or to the specific recipient, where
applicable.

21

ISO 13485

DESIGN AND MANUFACTURE OF MEDICAL DEVICES

Clause 7.5.2.1
The organization shall establish documented
procedures for the validation of the application of
computer software (and changes to such software
and/or its application) for production and service
provision that affect the ability of the product to
conform to specified requirements.
Such software applications shall be validated prior
to initial use.
22

ISO 13485 : 2015

DESIGN AND MANUFACTURE OF MEDICAL DEVICES

Will explicitly mandate:

That software used as part of the quality
system must be validated and subject to
change control.
That we must have procedures to govern
this
That validation must be documented and
the documentation maintained.
23

FDA LAB MANUAL OF QUALITY PROCEDURES

http://www.fda.gov/ScienceResearch/FieldScience
/LaboratoryManual/ucm174286.htm

24

25

4.5.3 VALIDATION OF SPREADSHEETS

SUMMARY

Lock all non-input cells

Make spreadsheets read-only, with password protection
Automatically reject data outside valid ranges
Positive and negative testing: Test by entering expected and
extreme values, and nonsensical data
Keep record of all cell formulas
Document changes made to the spreadsheet
Change control with version numbers
Periodic re-validation spreadsheets, including
verification of cell formulas
manual verification of spreadsheet calculations
26

FDAS INTERNAL GUIDELINES

FOR SPREADSHEET DESIGN AND VALIDATION
Spreadsheet Design and Validation for the MultiUser Application for the Chemistry Laboratory: Part I
www.spreadsheetvalidation.com/pdf/LIB_Design_MultiUser2A.pdf

Spreadsheet Design, Verification and Validation,

Use and Storage of Single-User Workbook Files in the
US FFDA Laboratories: Part II
www.spreadsheetvalidation.com/pdf/LIB_Part_II_SingleUser.pdf
27

COMMON SPREADSHEET ISSUES FOUND BY

FDA IN INDUSTRY
Spreadsheet files not maintained, some deleted
Rounding errors
Formulas don't match (Excel vs source, Excel vs manual
calculation)
Conversion factors issues
Spreadsheet doesn't show specs or limits
Unclear documentation
Units not labeled
Weights described as volumes, areas as ratios
Security and data integrity issues
Cells not locked
Regressions that inverted X and Y axis
28

PART 2: VALIDATING THE

SPREADSHEET
VALIDATION PLAN, EXECUTION, REPORTING

29

VALIDATING YOUR SPREADSHEET

Validation :
Provide documented
evidence that the
spreadsheet does what it
is intended to do,
correctly, and consistently
30

TYPICAL VALIDATION ELEMENTS

Validation Plan
Requirements Specification
Design Specification
Traceability Matrix
Testing

Development
Installation Qualification
OQ / PQ
-orSystem / User Acceptance

Validation Report
Procedures & Governance
Templates

You can use

separate documents
for each

-ORA single Validation

Protocol that
includes ALL
validation elements
31

GOVERNANCE
Spreadsheet Validation Procedure
Outlines HOW spreadsheets will be validated
What document(s) need to be produced
Roles and responsibilities, Authors and Approvers, etc.

Templates (i.e. Spreadsheet template)

Change Control Procedure
May be a separate procedure, or part of the main
Spreadsheets Validation Procedure

Validated Spreadsheet Inventory

Training
32

GENERAL INFORMATION
Spreadsheet name
Description and Purpose
What the spreadsheet will be used for
Process(es) supported
Where it will be used

References
Analytical methods, SOPs, etc.

33

REQUIREMENTS
Describes, with detail, WHAT you want the
spreadsheet to do.
Requirements should be numbered
MS Excel version required
Excel Add-Ins required, if any
OS version in which it is developed
For example: MS Windows 7 SP1, Mac OS X 10.10
Include OS service pack, if applicable

34

REQUIREMENTS
Input cell and formula cell requirements
Formatting (colors, font size and type, etc.)
Data validation (field type, size, etc.)

Descriptions for every formula, and source

Page formatting
Titles
Headers
Footers

35

REQUIREMENTS
Charts and Graphs
Title and Description of each
Required labels for each axis

Security requirements
Password protection

Output requirements
Color printer, PDF-creating software
Specific folder in a specific shared drive
Automatic eMail to specific people

36

DESIGN SPECIFICATION
Describes, with details, HOW the spreadsheet will
comply with the Requirements

Address all requirements, individually or by groups

Describes the actual spreadsheet as written
Shows actual EXCEL version of formulas
Describes algorithms used, if any
Describe conditional cell formatting used, if any
Describe data validation used, if any
Describe outputs produced (i.e. graphs)

38

TRACEABILITY MATRIX
Traces every requirement to its
corresponding design
element, and to the test
script(s) where the
requirement is challenged and
tested.

39

DEVELOPMENT TESTING & DRY RUNS

Recommended!
Typically not documented formally
Dev Testing helps discover bugs and fix them while
were not yet in formal validation.
Dry Runs help discover issues with the validation test
scripts, and allows us to fix these before we move
into formal document change control.
40

INSTALLATION QUALIFICATION (IQ)

IQ includes Installation and Configuration
State all prerequisites, ensure they are met prior to
execution

List all spreadsheet files that have to be installed

List location and path where spreadsheet files will
be installed
Development environment does not have to be validated
Test environment may need to be validated
Production environment must be validated
41

OPERATIONAL QUALIFICATION (OQ)

State all prerequisites, ensure they are met prior to
execution
Verify that all requirements documented in the
Requirements section are met
Ensure all outputs have the correct formatting
Provide printouts of all formulas, input values
used, output results.

Positive v Negative testing !!!

Security testing
Performance testing
Simulate output issues
42

OPERATIONAL QUALIFICATION (OQ)

Ensure all non-input cells are locked
Ensure conversion factors are correct
Ensure spreadsheets are read-only, with password
protection
Ensure the spreadsheet automatically rejects data
outside valid ranges
Test for rounding errors
Ensure Excel formulas match the source formula
Ensure formula input / output cells are correct
Compare formula results vs manual calculations
Ensure units and spec limits are present and correct
43

OQ: POSITIVE VS NEGATIVE TESTING

Positive testing : test and verify every single
formula using values that should produce correct
results
Ensure the spreadsheet produces correct results for
various input data sets
i.e. at least two data sets
Data set 1: known to result in a PASS decision
Data set 2: known to result in a FAIL decision

Include test cases with borderline data

Verify spreadsheet results against results from
manual calculations
44

OQ: POSITIVE VS NEGATIVE TESTING

OQ
Negative testing :
Use incorrect inputs to ensure
the spreadsheet is robust, able
to handle them without crashing
or producing false or incorrect
outputs, and that it is not
possible to bypass security

45

OQ: POSITIVE VS NEGATIVE TESTING

Negative testing examples:
Required data entry : ensure input fields cannot be left
blank
Field type test: ensure data entered is of the correct type
(i.e. dates, alphanumeric, etc.)

Enter alpha or special (@%^#) characters on a numeric field

Enter a decimal number in an integer field
Enter negative numbers in a positive numbers field
Enter nonsensical inputs (i.e. ASCII CRTL codes)

http://academic.evergreen.edu/projects/biophysics/technotes/program/ascii_ctr
l.htm

Field size test: ensure user can only enter the specified
number of characters in a field

46

OQ: POSITIVE VS NEGATIVE TESTING

Negative testing examples:
Date bounds test: test upper and lower bounds for dates.
Numeric bounds test: for example, if the number in a field
should be between 10 and 50, the system should not
accept numbers lower than 10, and higher than 50.
Numeric limits test: make sure the spreadsheet doesnt
crash or produce incorrect output when entering a number
outside of Excels limits:
Excel 2013 limits:
https://support.office.com/en-za/article/Excel-specifications-and-limitsca36e2dc-1f09-4620-b726-67c00b05040f
47

OQ: POSITIVE VS NEGATIVE TESTING

For a good discussion, with
examples, of Positive vs
Negative software testing,
please refer to:
http://www.softwaretestingcl
ass.com/positive-andnegative-testing-in-softwaretesting/

49

OQ SECURITY TESTING
Security testing:
Ensure it is not possible to:
Unlock locked cells / worksheets
Alter formulas, output results,
output graphs /charts/ tables
Add or remove worksheets

50

OQ PERFORMANCE TESTING
Output issues : ensure the spreadsheet behaves as
expected when you
disconnect printer
close the PDF-rendering application
Performance :
Multiple users simultaneously
Open multiple instances of the spreadsheet at the
same time
Execute spreadsheet while various other
applications are running
51

OPERATIONAL QUALIFICATION
Formula Auditing
Excels Formula Auditing tools allows us to demonstrate that
the inputs come from the expected cells

52

TEST EXECUTION
Ensure test scripts are
executed in the appropriate
sequence.
Document deviations when
actual results do not match
expected results
Take screenshots and printouts
as documented evidence
53

TEST EXECUTION
Include all executed test scripts
Include all screenshots, printed
outputs, manual calculations
Post-approvals

54

CHANGE CONTROL AFTER VALIDATION

Update Validation documentation
Additional or changed requirements
Corresponding design elements changes

Update Testing
New or updated test scripts
Test new functionality (i.e. new/updated formula)
Regression testing: ensure areas not changed still work
correctly

Update traceability matrix

Upon release, increase the Version number
REMOVE ACCESS to the old version
55

VALIDATION: HOW MUCH IS TOO MUCH?

Depends on the level of risk

56

PART 3:
BUILDING THE SPREADSHEET
DESIGN A COMPLIANT SPREADSHEET

57

CHANGE CONTROL
Spreadsheets used for GxP processes should be
subjected to formal version control and validation.
The organizations change management system
should be used to document whenever we:
Create a new spreadsheet for regulated / validated uses
Make changes to a validated spreadsheet
Retire/decommission a validated spreadsheet
Move a validated spreadsheet to a different version of
Excel (i.e. from Excel 2007 to Excel 2010) from the one used
in development and validation
Move a validated spreadsheet to a different operating
system (i.e. from Windows to Linux or MacOS)

58

CREATING THE SPREADSHEET

The following information (at minimum) should be
included on the main worksheet:
Spreadsheet Name
Version number
Date of last modification
Every printout should contain
this information

59

CREATING THE SPREADSHEET

Verify formulas against sources

Use correct units of measurement
Lock all non-input cells
Disable column/row add/remove
Unlock input cells
Distinguish input, calculation (formula) vs output
cells
Cell background color
Font : bold, italics, size, color

Use conditional formatting on output cells

Different cell background color and/or font color for results
that pass vs results that fail
60

CREATING THE SPREADSHEET

Add a field where the user will enter his/her name
every time the spreadsheet is used.
Use Page Setup to print the following information:
Spreadsheet filename
Correct date and time
Page numbers and total pages

Make the spreadsheet read-only

61

UNITS CONVERSION
You can use the Excel CONVERT function to convert
values from one unit to another in your formulas
Click HELP in Excel for a list of all units included.

62

CHANGE HISTORY
Each spreadsheet should have a Change History
worksheet (a.k.a. Revision History)
Every time the spreadsheet is updated, an entry
should be made in this Change History:

New version number

Date of change
Change control number
Name of person(s) who made the change
Itemized description of ALL changes made (with DETAILS)
63

SECURITY LAYERS
Lock all cells except user input cells.
HOME tab/ CELLS group/ Format / Protection

Password-protect the worksheet

Prepare / Encrypt document

Install the validated spreadsheet in a protected

folder on a networked shared drive
Access to the folder should only be given to authorized
personnel

OR save the validated spreadsheet as a controlled

document in your EDMS
64

IMPORTANT !!!
Locking / unlocking cells
Protect spreadsheets /worksheets
Cell formatting:
Data types
Look and feel : Font, Colors

Validation criteria definitions for input cells

Define formulas
Use of logical statements in formulas
Use of Page Set-up

65

PART 4: WORKSHOP
HANDS-ON SPREADSHEET WORKSHOP

66

SPREADSHEET CREATION
Once you create your spreadsheet
1. ID cell types, by color
2. Conditional formatting for displaying results

3. Data validation
4. Formula auditing

Trace Precedents and Dependents

Show and evaluate formulas
Error checking
Preventing formulas from being displayed

5. Set print headers and footers

67

SPREADSHEET SECURITY
6. Protect the Worksheet
7. Unprotect input cells
8. Protect the Workbook
9. Protect and SHARE the Workbook
10. Tracking Changes

68

1. ID CELL TYPES BY COLOR

Input Cells:
Output Cells:

Yellow background, red text

Lt Blue background, black text

69

2. CONDITIONAL FORMATTING
Conditional formatting can be used to change the
formatting of a cell (background color, text color,
text properties, etc.) depending on its content, or
on the content of another cell

70

2. CONDITIONAL FORMATTING
You can apply multiple formatting rules
to a single cell
Use Manage Rules to keep track of the
rules you are applying.

71

2. CONDITIONAL FORMATTING
Example 1
Minimum spec value is 14, maximum is 17
We want cells to be:
Lt Green fill and Dk Green text IF value is between min and max
Lt Red fill and Dk Red text IF value is outside min and max

1. Home / Styles / Conditional Formatting/ Highlight Cell Rules/ Less

Than => dialog box
2. Select cell where minimum value is listed, and desired formatting:

72

2. CONDITIONAL FORMATTING
Example 1 (cont.)
3. Home / Styles / Conditional Formatting/ Highlight Cell Rules/ Greater
Than => dialog box
4. Select cell where maximum value is listed, and desired formatting:

5. Home / Styles / Conditional Formatting/ Highlight Cell Rules/

Between => dialog box
6. Select cells where maximum and minimum values are listed, and
desired formatting:

73

2. CONDITIONAL FORMATTING
Example 2:
Have a cell that shows PASS or FAIL depending on the value of
another cell
We want
PASS: Lt Green fill and Dk Green text
FAIL: Lt Red fill and Dk Red text
1. = IF ({cell} <= {min value}, FAIL,PASS)
2. = IF ({cell} >= {max value}, FAIL,PASS)
3. Home / Styles / Conditional Formatting/ Highlight Cell Rules/ Text that
Contains => dialog box
4. Format Cells that contain: FAIL
with Lt Red Fill with Dk Red Text
5. Format Cells that contain: PASS
with Lt Green Fill with Dk Green Text
74

2. CONDITIONAL FORMATTING

3. DATA VALIDATION
Use Excels Data Validation tools to enforce limits in
input fields.
Examples:

Integer input between 1 and 20

Alphanumeric field, from 1 to 16 characters
Date or time
Decimal number greater, lower or than a specific value; or
between specific values

Excels Data Validation also allows you to:

Display custom messages on input cells
Display custom error messages when input is outside
parameters
78

3. DATA VALIDATION TOOLS

79

3. DATA VALIDATION - SETTINGS

Define the types of
content that is allowed
on the cell
In this case the cell is
restricted to positive
decimal values

80

3. DATA VALIDATION INPUT MESSAGE

Enter the Title and Input
Message to be displayed
when the mouse pointer
hovers over the selected
cell

81

3. DATA VALIDATION ERROR ALERT

Enter the Error Alert
message to be displayed
if the data entered does
not meet the restrictions.

82

3. DATA VALIDATION DATA TYPES

Types of inputs:

Any value
Whole number
Decimal
List
restrict input to items from a specified list
List should be included in a protected
column in the spreadsheet

Date
Time
Text length
Custom
83

3. DATA VALIDATION
Example: restrict field to specific length

84

3. DATA VALIDATION
Example: restrict possible values of a cell to those in
drop-down list

85

3. DATA VALIDATION
Example: prevent future dating
Allow:
Data:
End Date:

Date
less than or equal to
=INT(NOW())

If you want a date field to always auto-populate with the

date the spreadsheet is executed, put =INT(NOW()) as the
field value for that cell, and LOCK the cell (dont make it an
input field). The user will not be able to modify that date.

86

3. DATA VALIDATION
Custom:
Example: ensure the entry in a column is a number
1.
2.
3.
4.
5.
6.

Select the column

select Data, Validation
Select the Settings tab
Select Custom from the Allow list
In the Formula field, enter =ISNUMBER(c1)
Click OK

The ISNUMBER function returns TRUE if the cell contains a

number
87

4. FORMULA AUDITING

4.1 Preventing formulas from being displayed

4.2 Trace Precedents and Dependents
4.3 Show and evaluate formulas
4.4 Error checking
88

4. FORMULA AUDITING
4.1 How to prevent your formulas from being displayed in the formula bar:

89

4. FORMULA AUDITING
4.1 How to prevent your formulas from being
displayed in the formula bar:
1. Select formula cell
2. Right click and select Format Cell
-OR- Home / Cells / Format / Format Cells
3. Protection:
[] Locked
[] Hidden
4. OK
5. Review / Changes / Protect Sheet
=> your formula will not be visible in the formula bar any longer

90

4. FORMULA AUDITING
4.2 How to trace Precedents and
Dependents in your formulas:
Precedents
1. Select formula cell
2. Formulas / Formula
Auditing / Trace Precedents

Excel will display arrows

showing which cells your
formula inputs come from
Remove arrows deletes the
arrows
91

4. FORMULA AUDITING
4.2 How to trace Precedents and
Dependents in your formulas:
Dependents
1. Select formula cell
2. Formulas / Formula
Auditing / Trace Dependents
Excel will display arrows
showing which cells your
formula sends outputs to
Remove arrows deletes the
arrows
92

4. FORMULA AUDITING
4.3 How to show and evaluate your formulas:

Show your formulas:

Formulas / Formula Auditing / Show Formulas

93

4. FORMULA AUDITING

94

4. FORMULA AUDITING

95

4. FORMULA AUDITING
4.3 How to show and evaluate your formulas:

Evaluate your formulas:

Select a formula cell

Formulas / Formula Auditing / Evaluate Formula

Keep pressing EVALUATE, and Excel will show you step-by-step,
with all intermediate values, how it evaluates your formula and
calculates a result

96

4. FORMULA AUDITING

97

4. FORMULA AUDITING
4.4 Formula Error Checking
If there are errors in a formula
(for example, entering a letter in
a numerical input cell), Excel will
show a #VALUE! error message
Click on Formula / Formula
Auditing / Error Checking

98

4. FORMULA AUDITING

Error Checking will display the cause of the error (wrong data
type in this example)

99

4. FORMULA AUDITING
From this dialog box you can:
Get HELP on the error type
Show calculation steps (same as Evaluate Formula).
You can see the step-by-step calculations Excel is
performing to evaluate your formula
Ignore Error:
error checking will continue checking the rest of your
spreadsheet and stop at all errors until its done
Edit in formula bar:
Edit the formula cell

100

5. SET PRINT HEADERS & FOOTERS

1. File / Print / Page Setup / Header & Footer
2. Header: Custom header
Left:
Page & [Page] of & [Pages]
Center: & [Tab] v1.0
Right: & [Date] & [Time]

Page x of xx
Worksheet name and version
Date and time

3. Footer: Custom footer

Left:
& [Path] & [file]
Path and filename
Center: CONFIDENTIAL (use [A] icon to format text)
Right: nothing
add anything you want
4. OK

101

5. SET PRINT HEADERS & FOOTERS

102

5. SET PRINT HEADERS & FOOTERS

103

6. PROTECT YOUR WORKSHEET

1. Review tab / Changes group / Protect Sheet
2. Select locked cells
3. Select unlocked cells
4. Enter and re-enter worksheet password

This password-protects your worksheet cells from any changes

This also disables Column & Row Add / Remove
BUT someone can still delete, add, and rename worksheets from
the spreadsheet
=> Protect Workbook
104

6. PROTECT YOUR WORKSHEET

105

7. UNPROTECT INPUT CELLS

1. Review tab / Changes group / Unprotect Sheet
2. Enter password, press OK

=> worksheet is now unprotected

3. Click on Allow Users to Edit Ranges

4. When the Allow Users to Edit Ranges dialog box opens, click on
NEW
5. When the New Range dialog box opens:
Title:
<any title you want>
Refers to cells:
range of input cell(s)
Range Password:
<dont pwd protect>
OK, OK
6. Click on Protect Sheet : enter worksheet password, then OK
7. Now you can only change the values of the selected input cells

106

7. UNPROTECT INPUT CELLS

107

7. UNPROTECT INPUT CELLS

108

7. UNPROTECT INPUT CELLS

109

8. PROTECT YOUR WORKBOOK

1. Review tab / Changes group / Protect Workbook
2. [] Structure
3. [ ] Windows
4. Password: enter and re-enter worksheet password

When the worksheet is protected, you cant add, remove, or rename

worksheets in the MS Excel file
To unprotect, click on Review / Changes / Protect Workbook and
enter the password

110

8. PROTECT YOUR WORKBOOK

111

9. PROTECT AND SHARE WORKBOOK

Once you are ready to publish your spreadsheet,
use Protect and Share Workbook
1. Review / Changes / Protect and Share Workbook
2. [] Sharing with Track Change
3. Enter and re-enter worksheet password
4. SAVE the file

The file will be saved, and will be ready for sharing

Options to unprotect cells and worksheet will be Disabled
112

9. PROTECT AND SHARE WORKBOOK

113

10. TRACKING CHANGES

114

10. TRACKING CHANGES

Excels Track Changes functionality displays:

Cells changed
Date and time
User who changed it
Old and new value

Helpful when you are editing a spreadsheet

However it should not be used as a Part 11compliant audit trail
Can be turned on and off
115

10. TRACKING CHANGES

When you turn on Track Changes, Excel will mark
every cell you edit/change.
If you hover the mouse pointer over the cell it will
display the change information.

Once you SAVE your worksheet, the change marks

are removed
116

10. TRACKING CHANGES

You can get a report that will show you all the changes
made to the spreadsheet since the last save
Review / Changes / Track Changes/ Highlight Changes

117

10. TRACKING CHANGES

118

10. TRACKING CHANGES

If you want to review and Accept / Reject changes:
Review / Changes / Track Changes/ Accept-Reject Changes

119

QUESTIONS

120

Thank You !

121