Excel spreadsheets are commonly used in the pharmaceutical industry for calculations and data analysis. To ensure that these spreadsheets meet the requirements of FDA 21 CFR Part 11, they must be validated. Here is a step-by-step procedure for Excel spreadsheet validation:
By following this step-by-step procedure, Excel spreadsheets can be validated for FDA 21 CFR Part 11 compliance.
1. Preparation of Master Calculation Sheet:
- Prepare the calculation sheet using Microsoft Excel.
- Format the cells by creating variables required for the calculation of individual tests.
- Protect the cells using a password where no variables/readings need to be entered or where a formula has been created for the calculation of results.
- Validate the input of cells where variables/readings need to be entered.
- Prepare the calculation sheet for individual product/calculation or for individual tests if required.
- Arrange the formula in the resulting cell by selecting cells that contain formula data.
- Protect the calculation bar, result bar, etc. from the users after validating the calculation sheet.
Key Takeaways
- Microsoft Excel is a useful tool for creating calculation sheets.
- Variables should be established in cells for individual test calculations.
- Protect cells with passwords when no further data entry or formulas are required.
- Validate input in cells where variables or readings need to be entered.
- Tailor calculation sheets for specific products or individual tests if necessary.
- Arrange formulas in resulting cells by selecting the relevant data cells.
- Secure sensitive elements like the calculation bar and result bar after validating the sheet.
2. Validation:
- Excel sheet validation should be performed using a protocol.
- Calculation sheets need to be validated before they are used.
- Use a scientific calculator to perform calculations on the sheet.
- Record the calculations and observations for reference.
- Check for the protection of inactive cells in the sheet.
- Validate active cells by inputting incorrect data and reporting the output.
Key Takeaways
- Excel sheet validation is important to ensure the accuracy and reliability of calculations.
- A protocol should be established to guide the validation process.
- Validation should be carried out for every newly prepared calculation sheet.
- Use a scientific calculator to perform calculations to minimize errors.
- It is crucial to document the calculations and observations made during the validation process.
- Pay attention to the protection settings of inactive cells in the calculation sheet.
- Validating active cells by intentionally entering incorrect data helps identify any anomalies or errors in the output.
3. Acceptance Criteria:
- The results obtained using the calculator should not differ from the results reported using the calculation sheet.
- The protected cells should not allow the feeding of any data.
- Any validated cell should allow the user to input the data within the specified range.
- Maintain the profile of Excel sheets.
Key Takeaways
- Results obtained using the calculator should match the results reported using the calculation sheet.
- Protected cells should be unable to accept any data input.
- Validated cells should only allow the user to input data within the specified range.
- It is important to maintain the profiles of Excel sheets.
4. Numbering of The Excel Sheet:
- The access to the Master Calculation Sheets is controlled by the Head of the Department using a password.
- Password shall consist of not less than six, and not more than eight alphanumeric numbers.
- Password shall be changed by Head QC whenever required.
- Number the Master Calculation Sheets using alphanumeric Characters.
ALSO READ: Why Three Batches are Taken for Validation?
5. Usage of Calculation Sheet
- Open the shared drive of Excel Sheet Validation.
- Select and open the sub-folder identified by the product name and test name for which the calculation needs to be performed from the above main folder.
- Drag the desired file name with the help of the cursor and double-click on it to open the calculation sheet.
- Enter the password to open the Excel sheet.
- The window now appears as “Read Only Mode”.
- Enter the Product name, Batch number, Stage, and date in the respective columns provided in the calculation sheet.
- Enter the variables like Area, Absorbance, Weight, and Potency of Working Standard/Reference Standard, etc., in the space provided for the respective columns.
- Print the calculation sheet.
6. Control of Excel sheet:
- Create a profile of the calculation sheet.
- Maintain a list of Excel sheets for analysis.
- The calculation sheet shall be revised whenever the standard test procedure is revised if required.
- For the revision of Excel sheets, the Request form shall be filled.
- The Master Calculation Sheets should be made obsolete once an updated version of the same is put into use.
- Review the calculation sheets whenever the Microsoft Excel base programmer undergoes an up-gradation.
7. Verification of Excel sheets:
- Perform verification of Excel calculation sheets once in two years.
- Verify calculations using the calculation sheet with a scientific calculator.
- Record the report for Excel sheet validation as per the following data:
INSTRUMENT USAGE LOGBOOK
Name of the Instrument:_______________
Instrument ID:_______________
Tags
Validation
