EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11

 

Preparation of Master Calculation Sheet: excel spreadsheet validation for fda 21 cfr part 11

·       Prepare the calculation sheet by using Microsoft Excel.

·       Format the cells by creating variables as is required for the calculation of individual tests.

·       Protect the cells using password, where no variables / readings need to be entered or where formula has been created for calculation of results.

·      Validate the input of cells where variables/readings need to be entered.

·       Prepare the calculation sheet for individual product/ calculation or may be for individual test if required.

·       Arrange the formula in resulting cell by selecting cells which contains formula data.

·        Protect the calculation bar, result bar etc. from the users after validating the calculation sheet.

Validation:

·         Prepare protocol for excel sheet validation (Format at the end of Article)

·         Perform validation for every newly prepared calculation sheet prior to use.

·         Perform calculation using calculation sheet with scientific calculator.

·         Record the calculations and observations (Format at the end of Article)

·         Check for the protection of inactive cells in the calculation sheet.

·         Perform the validation of active cell by filling wrong entry and report the output.

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 feeding of any data.

·         Any validated cell should allow user to input the data within specified range.

·         Maintain the profile of excel sheets (Format at the end of Article)

Numbering of The Excel Sheet: excel spreadsheet validation for fda 21 cfr part 11

·         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 Character

Usage of Calculation Sheet:

·       Open the share drive of Excel Sheet Validation.

·       Select and open the sub-folder identified by the product name and test name for which calculation needs to be performed from the above main folder.

·       Drag the desired file name with the help of cursor and double click on it to open the open the calculation sheet.

·        Enter the password to open the excel sheet.

·       Window now appears “Read Only Mode”.

·        Enter Product name, Batch number, Stage and date in the respective columns provided in calculation sheet.

·        Enter the variables like Area, Absorbance, Weight and Potency of Working Standard / Reference Standard etc., in space provided for the respective columns.

·        Print the calculation sheet.

Control of Excel sheet:

·         Create a profile of calculation sheet in the format (Format at the end of Article)

·         Maintain a list of excel sheets for analysis in the format (Format at the end of Article)

·         The calculation sheet shall be revised whenever standard test procedure revised if required.

·         For revision of excel sheets 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.

Verification of Excel sheets:

·         Perform verification of Excel calculation sheets once in two years.

·         Verify calculations using calculation sheet with scientific calculator.

·         Record the report for excel sheet validation as per following data:

·         INSTRUMENT USAGE LOG BOOK

 

·         NAME OF INSTRUMENT: _________________________                                                                                 ID. No.: __________________

S. No.	Date	Product Description	Batch No./ AR. No.	Usage Time		Operated By
				From	To

 

Read More Validation Guidelines Here