C VALIDATE FDA-COMPLIANT MS EXCEL … B_Soto_pres.pdf•Keep record of all cell formulas ... (i.e. Spreadsheet template) ... •Ensure formula input / output cells are correct

1

R A U L S O T O , M S C , C Q E

I V T A P R I L 2 0 1 5 P H I L A D E L P H I A

SPREADSHEET VALIDATION 101: CREATE AND VALIDATE FDA-COMPLIANT

MS EXCEL SPREADSHEETS

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 [email protected]

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

5R E G U L A T I O N S G O V E R N I N G S P R E A D S H E E T S

PART 1: REGULATORY

PERSPECTIVE

WHICH SPREADSHEETS NEED TO BE

VALIDATED?

If the spreadsheet supports any activity governed by

applicable regulations, it should be validated

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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

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FDA 483

Pharmaceuticals (Eli Lilly):

FDA WARNING LETTERS

http://www.contractormisconduct.org/ass/contractors/18/cases/305/221/f

da-warning-letter.pdf

Pharmaceuticals (Cardinal Health):

FDA WARNING LETTERS

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

369409.htm

Pharmaceuticals (Aarti Drug Limited):

FDA WARNING LETTERS

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

cm075766.htm

Biologics (National Genetics Institute):

FDA WARNING LETTERS

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

56498.htm

Medical Devices (Aubrey Inc.):

FDA WARNING LETTERS

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

Medical Devices (B. Braun Medical Ltd):

FDA WARNING LETTERS

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

Medical Devices (Eldon Biologicals A/S):

FDA WARNING LETTERS

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

Medical Devices (EP Medsystems):

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.

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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

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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.”

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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).

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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 13485DESIGN 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.

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ISO 13485 : 2015DESIGN 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.

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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 calculations26

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

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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

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29V A L I D A T I O N P L A N , E X E C U T I O N , R E P O R T I N G

PART 2: VALIDATING THE

SPREADSHEET

VALIDATING YOUR SPREADSHEET

• Validation :

Provide documented

evidence that the

spreadsheet does what it

is intended to do,

correctly, and consistently

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TYPICAL VALIDATION ELEMENTS

• Validation Plan

• Requirements Specification

• Design Specification

• Traceability Matrix

• Testing

• Development

• Installation Qualification

• OQ / PQ -or-

• System / User Acceptance

• Validation Report

• Procedures & Governance

• Templates31

You can use

separate documents

for each

-OR-

A single Validation

Protocol that

includes ALL

validation elements

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

• Training32

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.

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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

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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

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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

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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)

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TRACEABILITY MATRIX

• Traces every requirement to its

corresponding design

element, and to the test

script(s) where the requirement is challenged and

tested.

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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

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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 issues42

OPERATIONAL QUALIFICATION (OQ)

• Ensure all non-input cells are locked

• Ensure conversion factors are correct

• Ensure spreadsheets are read-only, with passwordprotection

• 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 correct43

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

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• 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

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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


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

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• 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/

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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

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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

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OPERATIONAL QUALIFICATION

• Formula Auditing

• Excel’s Formula Auditing tools allows us to demonstrate that

the inputs come from the expected cells

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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

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TEST EXECUTION

• Include all executed test scripts

• Include all screenshots, printed

outputs, manual calculations

• Post-approvals

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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 version55

VALIDATION: HOW MUCH IS TOO MUCH?

•Depends on the level of risk

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57D E S I G N A C O M P L I A N T S P R E A D S H E E T

PART 3: BUILDING THE SPREADSHEET

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)

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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

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• 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 outputcells

• 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 fail60


• 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

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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.

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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)

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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

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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

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66H A N D S - O N S P R E A D S H E E T W O R K S H O P

PART 4: WORKSHOP

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

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SPREADSHEET SECURITY

• 6. Protect the Worksheet

• 7. Unprotect input cells

• 8. Protect the Workbook

• 9. Protect and SHARE the Workbook

• 10. Tracking Changes

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1. ID CELL TYPES BY COLOR

• Input Cells: Yellow background, red text

• Output Cells: Lt Blue background, black text

69

2. CONDITIONAL FORMATTING

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• 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


71

• You can apply multiple formatting rules

to a single cell

• Use Manage Rules to keep track of the

rules you are applying.


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• 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:


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• 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:


74

• 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


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

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3. DATA VALIDATION TOOLS

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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

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3. DATA VALIDATION – INPUT MESSAGE

• Enter the Title and Input

Message to be displayed

when the mouse pointer

hovers over the selected

cell

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3. DATA VALIDATION – ERROR ALERT

• Enter the Error Alert

message to be displayed

if the data entered does

not meet the restrictions.

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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

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• Example: restrict field to specific length

84

3. DATA VALIDATION

• Example: restrict possible values of a cell to those in drop-down list

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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.

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3. DATA VALIDATION

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

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4. FORMULA AUDITING

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4.1 Preventing formulas from being displayed

4.2 Trace Precedents and Dependents

4.3 Show and evaluate formulas

4.4 Error checking

4. FORMULA AUDITING

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4.1 How to prevent your formulas from being displayed in the formula bar:

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

91

4.2 How to trace Precedents and

Dependents in your formulas:

• Precedents


• 2. Formulas / Formula

Auditing / Trace Precedents

Excel will display arrows

showing which cells your

formula inputs come from

Remove arrows deletes the

arrows

4. FORMULA AUDITING

92

4.2 How to trace Precedents and

Dependents in your formulas:

• Dependents


• 2. Formulas / Formula

Auditing / Trace Dependents

Excel will display arrows

showing which cells your

formula sends outputs to

Remove arrows deletes the

arrows

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

96

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

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

101

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


102


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


107


108


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

112

9. PROTECT AND SHARE WORKBOOK

113

10. TRACKING CHANGES

114


• 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

115


• 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 removed116


• 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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• 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 !

Documents

C VALIDATE FDA-COMPLIANT MS EXCEL … B_Soto_pres.pdf•Keep record of all cell formulas ... (i.e. Spreadsheet template) ... •Ensure formula input / output cells are correct