Spreadsheet Validation Ensuring
Laboratory Data Integrity
Thanabalan Subramanian
Roche Products Ltd
3rd April 2014 GSK, Stevenage
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Disclaimer
• The views and opinions expressed in this
PowerPoint presentation are those of of
my own and should not be attributed to
Roche Products Ltd
3rd April 2014 GSK, Stevenage
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Contents
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Scenario
The Plan
Some Spreadsheet Basics
Control
Simplification
Validation Approach
Conclusion
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Scenario
• A small manufacturing facility with
Chemistry and Microbiological labs
• couldn't get approval for a LIMS to be
implemented.
• Wanting to help Laboratory analysts
developed over 80 spreadsheets ranging
for calculation to trending spreadsheets.
• Unfortunately, forgot to validate these
spreadsheets!
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The Plan
• Needed to know exactly what the extent of
the problem
• Established an inventory, not by searching
servers and desktops, but by interviewing
• Which established culprits outside of the
lab, eg Engineering had steam quality
spreadsheets
• Developed a remediation plan, in parallel
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The Plan (2)
• Global SOP on Spreadsheet Validation
was developed
• Piloted 2 spreadsheet types: Calculation
and Trending
• Underlying target to minimise, if not
eliminate custom code.
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Spreadsheet Basics
• As Excel is on every desktop there’s a
Potential for a big problem
• A spreadsheet is a user developed
application
• Classify into 3 types of spreadsheets:
1. The single use, throw-away spreadsheet
2. The calculator spreadsheet
3. The Data spreadsheet
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Control
• The control of calculation and data type
spreadsheets.
• Initial thoughts were to use EDMS
• OK for calculation spreadsheets, but not
practical for data type spreadsheets
– Multiple checking in and out
– Audit trail
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Control (2)
• 2 options:
Build Customisation
Buy off the shelf solution
Build once, qualify and integrate
multiple times
Validate the wrapper solution once,
use multiple times
Large amount of customisation
Off the shelf package
Requires Excel VBA expertise
Multiple vendor offerings available
Time needed to develop
Available for use as soon as validated
Needs maintenance in house
Purchase user licence & maintenance
costs
Would still use eDMS for calculation
spreadsheets
Could use for both calculation & data
type spreadsheets
Increased standard functionality eg
security, e-sig
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Simplification
• A review indicated opportunities for
combining spreadsheets
• Unable to eliminate all customisation created a small piece of VBA for the
trending spreadsheets
• This was treated as a reusable module,
validated once, integrated multiple times
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Validation Approach (1)
• Generally, doesn’t differ from other
validation approaches
• Principles of specifications, planning,
testing & reporting are the same
• Difference: Scale & complexity
• Let us scale the validation: roles &
deliverables
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Validation Approach (2)
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Risk Assessment
Requirements
Design Specification
Configuration Review or VBA Code
Review
• Testing and reporting of Unit, Installation
and Functional/User acceptance testing
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Validation Approach (3)
• Risk Assessment – GxP, Gamp category:
Category
Function
Deliverables
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Native functions no
configuration
Specify, install & verify
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With configuration, eg
Specify, design, install,
calculation with cell reference to configuration review &
perform auto data
verify
manipulations
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Custom macros or nested
logic/lookup functions
Specify, design, unit
test, install, code review
& verify
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Validation Approach (3)
Specification:
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Validation Approach (4)
Configuration & Code Reviews:
• To ensure macros and/or formulas
– are correct against the specification
– captured for review, held in validation pack
• For VBA this should be by independent
expert
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Validation Approach (5)
Testing & Reporting:
• Covers installation &
functional/acceptance testing
– are correct against the specification
– captured for review, held in validation pack
• Level of testing commensurate with level
of risk & categorisation
• The installation into production follows
wrapper instruction
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Validation Approach (6)
Testing & Reporting:
• usage SOP per spreadsheet
• administrations, including access control,
error logging and change control SOPs
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References
• Spreadsheet Design and Validation for the Multi-User Application for
Chemistry Laboratory Part I, No. 4317, Laboratory Information
Bulletin Division of Field Science, Office of Regulatory Affairs, FDA
• Spreadsheet Design, Verification and Validation, Use and Storage
of Single-User Workbook Files in the US FDA Laboratories Part II,
No. 4349, Laboratory Information Bulletin Division of Field Science,
Office of Regulatory Affairs, FDA
• GAMP 5 Risk Based Approach to Compliant GxP Computerized
Systems
• Guidelines for the Development and Validation of Spreadsheets,
Working Group on Information Technology (AGIT), version 1, 01
Aug 2011
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Conclusion
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Internal approach based on guidance
Pilot to refine
Weigh up pro’s & cons about build or buy
Ongoing challenges:
– continued ownership, maintenance activities,
such as change control and archiving
– Archiving & changing versions of Excel
– New staff education program
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Questions?
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