1.1 To lay down a standard procedure to be followed for preparation of validated excel sheets.
2.0 SCOPE
2.1 This SOP shall be applicable to the procedure for preparation of validated excel sheets in Department of Quality assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 The validated Excel sheets should be prepared by the QA Personnel.
5.2 The validated Excel sheets are used for calculations and to demonstrate that the calculation is accurate.
5.3 It is the responsibility of the Head of concerned department / study director / analyst to use validated Excel sheets for calculation.
5.4 Preparation of excel sheets
5.4.1 Excel sheet shall be prepared for assays / preclinical studies as and when required.
5.4.2 Excel sheet shall be prepared by filling the required parameters for calculations.
5.4.3 Apart from the general parameters required, following are the details which should be mentioned in the excel sheet :
5.4.3.1 Study title,
5.4.3.2 Study No. (if any),
5.4.3.3 Test item name,
5.4.3.4 Batch No. / Lot No.
5.4.3.5 Working Standard No. and its potency (if any)
5.4.3.6 Name of Study director / study personnel / analyst,
5.4.3.7 Study initiation date,
5.4.3.8 Experiment initiation date,
5.4.3.9 Experiment completion date,
5.4.3.10 Parameter/s or data entered on,
5.4.3.11 Calculation template identification number
5.4.4 Each calculation template shall be given a unique identification number. The number shall consist of 14 characters:
5.4.4.1 TEMP-XXX-01-00
5.4.4.2 The first four characters are 'TEMP' for template.
5.4.4.3 Fifth character is '-'.
5.4.4.4 Sixth, seventh and eighth characters are department code.
5.4.4.5 Ninth character is '-'.
5.4.4.6 Tenth and eleventh characters are numbers showing the template number of that department.
5.4.4.7 Twelfth character is '-'.
5.4.4.8 Thirteenth and fourteenth characters are numbers showing revision number.
5.4.4.9 For example: The first template with no revision for Department of Quality Assurance shall be numbered as TEMP-QAD-01-00.
5.5 All the cells of the excel sheets containing formulas shall be locked.
5.6 Locking of cell containing formulas
5.6.1 Open the worksheet to be locked.
5.6.2 On the “REVIEW” tab, in the “CHANGES” group, click “Unprotect Sheet” (if sheet is protected). Protect Sheet changes to Unprotect Sheet when a worksheet is protected (Picture -1).
Picture- 1 Unprotect sheet option in Changes Tab in Microsoft Excel 2007
5.6.3 If prompted, type the password to unprotect the worksheet.
Note: Skip above step mentioned in section 5.6.2 if sheet is already unprotected.
5.6.4 Select the whole worksheet by clicking the “SELECT ALL” button (Picture -2). Picture- 2
Select all button in Microsoft Excel 2007
5.6.5 On the “HOME” tab, in the “FONT” group, click the format cell font dialog box launcher i.e. next to “FONT” (Picture-3).
Picture- 3 Font tab under home tab in Microsoft Excel 2007
5.6.6 On the “PROTECTION” tab, clear the “LOCKED” check box, and then click OK. This unlocks all the cells on the worksheet when you protect the worksheet.
5.6.7 In the worksheet, just select the cells to be locked. Multiple non adjacent cells can be selected by selecting the first cell and then pressing the “CTRL” button on keyboard followed by selecting of other cells to be locked.
5.6.8 On the “HOME” tab, in the “FONT” group, click the Dialog Box Launcher next to “FONT”.
5.6.9 On the “PROTECTION” tab, select the “LOCKED” check box, and then click OK.
5.6.10 On the “REVIEW” tab, in the “CHANGES” group, click “Protect Sheet” (Picture-4). Picture- 4
Protect option in Changes Tab in Microsoft Excel 2007
5.6.11 Set a password to protect the sheet.
5.6.12 In the “ALLOW ALL USERS OF THIS WORKSHEET TO” list, select the elements that need to be blocked.
5.7 Validation of Excel sheet
5.7.1 Validation of Formulas
5.7.1.1 Fill some dummy values in the excel sheet, the excel sheet will give some results. Cross check these results by manually calculating all the formulas mentioned with the help of certified calculator.
5.7.1.2 Document the calculations in the Excel sheet validation report as per Format F/QAD/021/01-00 and attach the printout of the excel sheet with dummy values to make it a complete report.
5.7.2 Validation of Protected Cells
5.7.2.1 In Microsoft excel-2007 place the cursor on the protected cell and enter any value, a pop-up should appear showing “The cell or chart that you are trying to change is protected and therefore read-only”.
5.7.2.2 Perform the same procedure for all the protected cells. If the pop-up window does not appear and the cell is not protected, QA personnel shall rectify the problem.
5.8 The Excel sheet shall be considered validated only if the results obtained by entering dummy values shall match with the manual calculations performed with the help of a certified calculator up to one decimal place and all the cells which contain formulas are proved to be protected.
5.9 Passwords of all protected sheets shall be generated and preserved by Head- QA.
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Excel Sheet
Validation Report |
F……………………. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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