SPREADSHEET VALIDATION 101:

CREATE AND VALIDATE FDA-COMPLIANT

MS EXCEL SPREADSHEETS
1

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 5
 WHICH SPREADSHEETS NEED TO BE
VALIDATED?
If the spreadsheet supports any activity governed by
applicable regulations, it should be validated

6
 FDA 483S AND WARNING LETTERS

• Companies have been cited by FDA for not

validating spreadsheets used for:

• In–process analytical calculations

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

7
 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

• Let’s 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.”

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 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.
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 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

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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
 FDA’S INTERNAL GUIDELINES
FOR SPREADSHEET DESIGN AND VALIDATION

• Spreadsheet Design and Validation for the Multi-

User Application for the Chemistry Laboratory: Part I
• www.spreadsheetvalidation.com/pdf/LIB_Design_Multi-
User2A.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_Single-
User.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 You can use
• Design Specification separate documents
• Traceability Matrix for each
• Testing
• Development -OR-
• Installation Qualification
• OQ / PQ -or- A single Validation
• System / User Acceptance Protocol that
includes ALL
• Validation Report
validation elements
• Procedures & Governance
• Templates 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

we’re 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.

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 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 doesn’t

crash or produce incorrect output when entering a number
outside of Excel’s limits:

• Excel 2013 limits:

• https://support.office.com/en-za/article/Excel-specifications-and-limits-
ca36e2dc-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-and-
negative-testing-in-software-
testing/

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
• Excel’s 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 organization’s 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: Yellow background, red text

• Output Cells: 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 Excel’s 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
• Excel’s 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: Date
• Data: less than or equal to
• End Date: =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 (don’t 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. Select the column

2. select Data, Validation
3. Select the Settings tab
4. Select Custom from the Allow list
5. In the Formula field, enter =ISNUMBER(c1)
6. 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 it’s 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] Page x of xx
Center: & [Tab] v1.0 Worksheet name and version
Right: & [Date] & [Time] 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: <don’t 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 can’t 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

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9. PROTECT AND SHARE WORKBOOK

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10. TRACKING CHANGES

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 10. TRACKING CHANGES

• Excel’s 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 11-

compliant audit trail
• Can be turned on and off

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 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
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 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

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10. TRACKING CHANGES

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 10. TRACKING CHANGES

• If you want to review and Accept / Reject changes:

• Review / Changes / Track Changes/ Accept-Reject Changes

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QUESTIONS

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Thank You !

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