ivt2015 amsterdam - spreadsheet validation

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RAUL SOTO, MSC, CQEIVT DECEMBER 2015 AMSTERDAM

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]

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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

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5REGULATIONS GOVERNING SPREADSHEETSREGULATIONS GOVERNING SPREADSHEETS

PART 1: REGULATORY PERSPECTIVE

RAUL SOTOIVT DECEMBER 2015 AMSTERDAM

WHICH SPREADSHEETS NEED TO BE VALIDATED?

• Companies have received observations from 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/fda-warning-letter.pdf

Pharmaceuticals (Cardinal Health):

FDA WARNING LETTERS

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm369409.htm

Pharmaceuticals (Aarti Drug Limited):

FDA WARNING LETTERS


Biologics (National Genetics Institute):

FDA WARNING LETTERS

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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.

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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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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

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26VALIDATION PLAN, EXECUTION, REPORTINGVALIDATION PLAN, EXECUTION, REPORTING

PART 2: VALIDATING THE SPREADSHEET


VALIDATING YOUR SPREADSHEET• validation, software. (NBS)

Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle. See: verification, software.

• Source: FDA Glossary of Computer System Software Development Terminology http://www.fda.gov/iceci/inspections/inspectionguides/ucm074875.htm

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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

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VALIDATED SPREADSHEETS INVENTORY

• You need to know which validated spreadsheets are being used, and where.

• Inventory document should contain:• Spreadsheet Name and number • Current Version• Area(s) where used• Owner• Location

• Protected network folder address• eDMS

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TYPICAL VALIDATION ELEMENTS• Validation Plan

• Scope• Requirements Specification• Design Specification• Traceability Matrix• Testing

• Development• Installation Qualification• OQ / PQ -or-• System / User Acceptance

• Validation Report• Procedures & Governance

• Templates

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You can create individual documents for each

deliverable-OR-

A single Validation Protocol that includes ALL

validation elements

VALIDATION PLAN SCOPE• 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• Specific• Testable• Traceable

• MS Excel version required • Excel Add-Ins required, if any

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REQUIREMENTS• Input / output cells and formula cells requirements

• Formatting (colors, font size and type, etc.)• Data validation (field type, size, etc.)• Expected input data and ranges, per input cell• Expected output result, per output cells• Any unit conversions required

• Descriptions for every formula• Source (USP, literature, SOP, etc.)

• 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• Watermarks

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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• Describe data validation used• Describe outputs produced (i.e. graphs, tables, etc.)• OS in which the spreadsheet was developed

• i.e. MS Windows 7 SP1, Mac OS X 10.1036

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.

• Use formula auditing!

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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 file(s) to be installed

• List network 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 issues

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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

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OPERATIONAL QUALIFICATION (OQ)

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• use the INFO command to provide information about the execution environment.

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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• 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_ctrl.htm

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

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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.softwaretestingclass.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• Force-close the PDF-rendering application• No data loss even if it crashes

• Performance :• Can it handle 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 spreadsheet Version number• REMOVE ACCESS to the old version of the spreadsheet

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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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VALIDATION: HOW MUCH IS TOO MUCH?

• Depends on the level of risk

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57DESIGN A COMPLIANT SPREADSHEETDESIGN A COMPLIANT SPREADSHEET

PART 3: BUILDING THE SPREADSHEET


FDA’S INTERNAL GUIDELINESFOR 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• Units: 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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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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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

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CREATING THE SPREADSHEET• Worksheets

• Main• Revision History• Any data tables needed

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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 containthis information, plus• Date / time of use• User

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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

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REVISION 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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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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SECURITY LAYERS• Lock all cells except user input cells.

• HOME tab/ CELLS group/ Format / Protection

• Password-protect the worksheet• File / permission / encrypt with password

• 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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68HANDS-ON SPREADSHEET WORKSHOPHANDS-ON SPREADSHEET WORKSHOP

PART 4: WORKSHOP


SPREADSHEET CREATIONOnce 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

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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


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• 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 box4. 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:


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• 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: PASSwith 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

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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 column2.select Data, Validation3.Select the Settings tab4.Select Custom from the Allow list5.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

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4. FORMULA AUDITING

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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

4. FORMULA AUDITING

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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

4. FORMULA AUDITING

4.3 How to show and evaluate your formulas:

Show your formulas:

•Formulas / Formula Auditing / Show Formulas

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4. FORMULA AUDITING

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4. FORMULA AUDITING

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4. FORMULA AUDITING

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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

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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

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4. FORMULA AUDITING

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

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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

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5. SET PRINT HEADERS & FOOTERS

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1. File / Print / Page Setup / Header & Footer

2. Header: Custom headerLeft: Page & [Page] of & [Pages] Page x of xxCenter: & [Tab] v1.0 Worksheet name and

versionRight: & [Date] & [Time] Date and time

3. Footer: Custom footerLeft: & [Path] & [file] Path and filenameCenter: CONFIDENTIAL (use [A] icon to format text)Right: nothing add anything you want

4. OK


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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

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6. PROTECT YOUR WORKSHEET

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7. UNPROTECT INPUT CELLS1. 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

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7. UNPROTECT INPUT CELLS

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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

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8. PROTECT YOUR WORKBOOK

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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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10. TRACKING CHANGES• “Quick and dirty” way to check if two worksheets (or

regions) are identical or not

• Only tells you if there is a difference, not what is it, or where

= AND (exact( range1, range2))

TRUE: identicalFALSE: not identical

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QUESTIONS

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Thank You !Thank You !


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