OBJECTIVE:
To lay down the procedure for to describe the procedure for Validation of ex.cel worksheets.
SCOPE:
This procedure is applicable for the excel worksheets in laboratory for calculation of analytical results.
RESPONSIBILITY:
Quality Control Officer / Executive are responsible to follow procedure as per the procedure mentioned in this SOP.
QC Head is responsible for implementation and compliance of the procedure as per this SOP.
ABBREVIATIONS
SOP : Standard Operating Procedure
QC : Quality Control
A.R. : Analytical Report
PROCEDURE:
Validation of Excel Work Sheets :
The Validated excel worksheets shall be stored in the respective Controlled excel worksheet folders of each department.
The Group leader/ Lab QA should issue an excel worksheet number to analyst for preparing the new excel worksheet.
The analyst shall take an A.R. No. for the excel worksheet validation activity.
The Group leader/Lab QA should assign the excel worksheet number in the following manner' QC/ Product Name/01-01, where 'QC' is the Quality control, Product Name, /01' is Sheet No. of test for same product, -01 indicate sheet version No. serial number for the sample.
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.
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.
The group leader should check the excel worksheet against the Guideline / MOA/Specification for calculation and formula.
If the workshe.et is found OK, then it must be validated before it is kept for usage.
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.
Enter the relevant details in the Validation Report for excel worksheet.
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.
Write the results obtained by software and manual calculation on the validation report.
Attach the excel worksheet print to the validation report.
Compare the results obtained by software and manual calculation and record the same in the validation report.
Mark the excel worksheet with an identification mark “ “to indicate that the excel worksheet has been validated. Move the excel worksheet to the “Controlled excel worksheet “folder. Review sheet will be maintained.
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.
The excel worksheet should be password protected and opened only after supplying the requisite Password. The password should' be treated as confidential information.
Acceptance Criteria: The results obtained manually and from excel worksheet should be comparable.
In case of obsolete validated excel worksheet, reviewer /Group leader should move the excel work sheet to the" Obsolete excel worksheet" folder
All the reports of excel validation should be maintained as history as per relevant SOP.
Tags
QC SOP