sop for operation for validation of excel worksheets

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4 years ago

1.0 OBJECTIVE
1.1 To describe procedure for procedure for Validation of ex.cel worksheets.
2.0 SCOPE
2.1 This procedure is applicable for Validation of excel worksheets of Quality Control Department
3.0 RESPONSIBILITY
3.1 Officer /Executive – QC
4.0 ACCOUNTABILITY

4.1 Head – QC
5.0 PROCEDURE

5.1 Operating Procedure

5.1.1 The Validated excel worksheets shall be stored in the respective Controlled excel worksheet folders.

5.1.2 The Group leader/ Lab QA should issue an excel worksheet number to analyst for preparing the new excel worksheet

5.1.3 The analyst shall take an A.R. No. for the excel worksheet validation activity.

5.1.4 The Group leader should assign the excel worksheet number in the following manner DB/QC/ES/001 where ‘DB’ is the company identity, ‘QC’ is identity of department, ‘ES’ denoted as Excel Sheet and ‘001’ is the unique serial number for the Validated Excel Sheet which is continuous in increasing order for different Excel Sheet.

5.1.5 Maintain a list for the excel worksheet numbers where the details of sample name /activity and tests for which the excel worksheet is recorded along with the validated by/on date. Refer Format

5.1.6 After assignment of the excel worksheet number the analyst should prepare the excel worksheet as per the requirement and submit to the group leader for review. One excel worksheet should contain only one test

5.1.7 The group leader should check the excel worksheet against the Guideline/MOA/ Specification for calculation and formula.

5.1.8 If the worksheet is found OK, then it must be validated before it is kept for usage.

5.1.9 Enter the values in the relevant cells. Results will be calculated by the prepared excel worksheet and the values are displayed. Obtain a printout of the excel worksheet.

5.1.10 Enter the relevant details in the Validation Report for excel worksheet, Refer Format

5.1.11 Calculate the results manually using the same values as in excel worksheets with the help of scientific calculator and report the results in the validation report for excel worksheets. Refer Format

5.1.12 Write the results obtained by software and manual calculation on the validation report.

5.1.13 Attach the excel worksheet print to the validation report.

5.1.14 Compare the results obtained by software and manual calculation and record the same in the validation report.

5.1.15 The sheet should be protected in such a way that analysts are able to enter the values and data only in the cells meant for variable values and analysis information data. All the other parts of the excel work sheet like the formula cells and the other cells and their formatting should not be available for modification to the analyst. The modification can be done only by the

reviewer and /or Group Leader. This can be done by activating the protection for excel worksheet and excel workbook.

5.1.16 The excel worksheet should be password protected and opened only after supplying the requisite password. The password should’ be treated as confidential information.

5.1.17 Acceptance Criteria: The results obtained manually and from excel worksheet should be comparable.

5.1.18 All the reports of excel validation should be maintained as history as per relevant SOP.

6.0 RELATED DOCUMENT
6.1 Nil

7.0 REFERENCE

7.1 In House

8.0 FORMATS
8.1 List for the excel worksheet numbers
8.2 Validation Report for excel worksheet
9.0 ABBREVIATIONS
9.1 QC Quality Control
9.2 QA Quality Assurance
9.3 QCA Quality Control Analytical
9.4 SOP Standard Operating Procedure
9.5 A.R. NoAnalytical Reference number