Excel-Spreadsheet Validation
What is Excel-Spreadsheet?
Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which
data is laid out in rows and columns — like a big table. Excel organizes data in columns and rows and can
perform calculations on that data using formulas.
Spreadsheets that are used to create static data tables that are not updated are treated as documents,
and as such, are out of scope of validation. Spreadsheets used as templates, should be managed in
accordance with applicable electronic document requirements and must be validated.
Application of Excel-Spreadsheet in Pharmaceutical Industry:
Excel spreadsheets are widely used in the pharmaceutical industry for a variety of purposes. For
examples:
✔ Data entry and storage: Excel spreadsheets can be used to store large amounts of data, such as
chemical compound information, clinical trial data, or manufacturing records. This data can then
be easily accessed and used.
✔ Calculations: Excel spreadsheets can be used to perform analytical calculations, such as potency
calculation.
✔ Data analysis and interpretation: Excel spreadsheets can be used to analyze data and identify
trends. This information can then be used to make decisions about product development,
manufacturing, or marketing.
✔ Reporting and visualizations: Excel spreadsheets can be used to create reports and
visualizations that help to communicate data in a clear and concise way. This can be helpful for
sharing information with stakeholders or presenting data to management.
✔ Project management: Excel spreadsheets can be used to track project progress, manage
budgets, and assign tasks. This can help to ensure that projects are completed on time and
within budget.
✔ Dosage calculations: Excel spreadsheets can be used to calculate drug dosages based on patient
weight, age, and other factors. This can help to ensure that patients receive the correct dosage
of medication.
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✔ Clinical trial data management: Excel spreadsheets can be used to track clinical trial data, such
as patient demographics, treatment outcomes, and adverse events. This information can then be
used to analyze the effectiveness of a drug or treatment.
✔ Manufacturing process monitoring: Excel spreadsheets can be used to monitor manufacturing
processes, such as critical process parameters that can be monitored using spreadsheets. This
information can then be used to ensure that the manufacturing process is consistent and
reproducible.
Why is validation required?
Excel-spreadsheet validation is an important part of ensuring the quality of pharmaceutical products. By
following the validation process, pharmaceutical companies can help to prevent errors in spreadsheets
and protect patient safety.
Here are the specific reasons why Excel-spreadsheet validation is required in the pharmaceutical
industry:
To ensure the accuracy of calculations: Spreadsheets are often used to perform complex
calculations, such as potency calculation. It is essential that these calculations are accurate in
order to ensure the safety and efficacy of pharmaceutical products.
To prevent errors: Spreadsheets are susceptible to errors, such as typos, incorrect formulas, and
corrupted data. These errors can lead to inaccurate results, which can have serious
consequences.
To comply with regulations: The pharmaceutical industry is subject to a variety of regulations,
including those that govern the use of spreadsheets. By validating spreadsheets, pharmaceutical
companies can demonstrate that they are in compliance with these regulations.
How to validate Excel-Spreadsheet?
The following are the key steps in validating an Excel spreadsheet:
● Change Control: Initiate change control for excel-spreadsheet validation. After approval of the
change control, proceed for validation formalities as described below.
● Create User Requirement Specification (URS): In the URS, include following (not limited to):
o Purpose
o Define data input cells
o Define data output cells
o The formula will be used for calculation
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o Lock the cells as appropriate (except data input)
o Location of the file
o ID of the file including version control.
o Change history
● Create a validation plan: Create a validation plan considering requirements of URS.
● Create the Excel-Spreadsheet: As per URS, create the spreadsheet template.
● Perform the validation tests: This includes entering test data into the spreadsheet and
comparing the results to the expected results. The tests should cover a range of input values,
including normal, extreme, and invalid values as defined in the plan.
● Document the validation results: This documentation should include the following:
▪ The test results
▪ Any findings or recommendations (deviation must be resolved before release of the
spreadsheet for use)
● Approve the spreadsheet for use: The spreadsheet should only be approved for use after the
validation process has been completed and the results have been approved.
Conclusion:
When using spreadsheets for GxP activities, there must be assurance that the results are valid and that
the application itself is fit for intended use. This includes protecting the spreadsheet from inadvertent
changes, verifying the reliability of the spreadsheet by comparison with known results from known data,
and ensuring that the spreadsheet is robust enough to handle unforeseen data input needs.
References:
Good manufacturing practices: guidelines on validation
US FDA 21 CFR Part 11
EU Annex 11: Computerised Systems
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