SOP for Excel Sheet Validation in Pharmaceuticals

Nowadays the majority of Pharmaceutical industries are using automated software to maintain their data like SAP, LIMS etc. But still, the use of Excel spreadsheets is valuable. The majority of the original data are saved in MS Excel files in Pharmaceutical and analytical fields.

Spreadsheets are mainly used to make monitoring of data easier. Students and researchers use a spreadsheet for statistics, data analysis, equilibrium calculations and other basic arithmetic calculations. Many critical spreadsheets need to undergo validation to ensure that the data they generate is accurate and secure. The validation lifecycle requirements are met using a generic documentation set which allows spreadsheet validation and implementation with two documented deliverables.

Compliance with the user’s applicable regulations is achievable using this flexible and cost-effective process. We can validate the Excel calculation sheets used in pharmaceutical calculations but that should be protected. Prepare separate calculation sheets for individual tests, which can be common for all products.

ALSO READ: Analytical Method Validation Protocol for Nystatin

SOP for Excel Sheet Validation in Pharmaceuticals

OBJECTIVE

To lay down a procedure for validation of Microsoft Excel worksheets to be used for analytical calculations.

SCOPE

This SOP is applicable for the validation of Excel worksheets to be used for analytical calculations in the Quality Control Laboratory at PharmaInfo Ltd.

RESPONSIBILITY

The validation Officer is responsible for designing and validating the worksheet for different tests.

The QC Manager is responsible for ensuring the accuracy of the validation worksheet.

QA Manager shall be accountable for the implementation of this SOP.

PROCEDURE

Control of Microsoft Excel worksheets:

• Prepare separate calculation sheets for individual tests, which can be common for all products.
• Protect the Excel sheet except for the cells that need to be filled in while calculating the results.
• All worksheets used in the laboratory shall be validated with the help of the IT department as per Attachment-I and approved by the QA department.
• The validation Officer shall design and validate the worksheet as per topic 4.3 for different tests and shall prepare a list heading “Validation Excel sheet Index” as per Attachment II.
• Each worksheet shall have a “Company” Logo in the left corner with the title “Company Name” in the center as a header.
• Each validated spreadsheet used for calculation shall be numbered as

QC/AA-BBB/CC

Where

QC represents Quality Control,

AA represents RM for raw materials,

FS for the Finished product

SS for Stability Product,

IM for intermediate products,

MS for miscellaneous samples,

BBB represents a unique incremental number.

CC represents version no. starting from 00.

ALSO READ: SOP for Analytical Method Verification

• Master Excel spreadsheet shall be stored in a separate folder on the computer of the administrator.
• Only the validation officer and QC manager shall have the rights to create new master Excel worksheets.
• The master worksheet modification and deletion rights shall also be there with the validation officer only.
• Master Excel worksheet shall be used for the purpose of calculations by the Laboratory Analysts from the computer terminals in the laboratory.

Worksheet Protection

• Each Excel spreadsheet shall be password-protected.
• The password shall be of eight characters having alphanumerical in nature and one alphanumerical character in capital letters.
• The password of each workbook shall be maintained as per Attachment III and will be kept by the validation officer and QC manager.
• The Excel worksheet shall be operational in “read-only” format and the user shall not be able to save any data on the sheet and user shall be authorized to take print only via the “Ctrl+ P” command.
• The addition or deletion of any row/column in the worksheet impacting the operation of the formulae shall be restricted. 

Validation Procedure

1. Availability of validated Spreadsheet. 

•  Acceptance criteria: Excel Sheet shall be available on a separate folder.

2. Wrong password. 

• An attempt shall be made to open the Excel workbook using the wrong password.
• Acceptance criteria: The Excel workbook shall not open with the wrong password and the system shall display the message accordingly. 
• (Note – Screen print carrying the system message shall be printed and attached with spreadsheet validation document.)

3. Alteration. 

• An attempt shall be made to alter the contents of the protected cells, carrying the formula and fixed contents.
• Acceptance criteria: The Excel workbook shall not allow alteration of contents in the protected cells and the system shall display a message accordingly. 
• (Note –The screen print carrying the system message shall be printed and shall be attached to the validation document).

4. Addition or Deletion of row/column

• An attempt shall be made to add or delete a row/column.
• Acceptance criteria: The Excel workbook shall not add or delete the row/column and the system shall display the message accordingly. 
• (Note: The screen print carrying the system message shall be printed and attached with a spreadsheet validation document.)

ALSO READ: SOP for Preparation of Validation Master Plan (VMP)

Verification of Calculations

• Each of the calculations shall be done by calculator as well as Excel sheet and results shall be compared.
• Results shall be rounded off up to the decimal point specified in the monograph.
• Each of the calculations involved in the Excel worksheet shall be verified using a calibrated calculator.
• Calculations done by the calculator shall be recorded.
• Prior to verification of calculation, it should be ensured that the formula to be used is as per the monograph.

Acceptance criteria

• There shall be no difference in calculated values using the Excel worksheet and calculator.
• (Note-The Excel worksheet carrying the calculated results shall be printed and recorded observation.)

Re-validation of Excel Sheets

• Excel sheets shall be revalidated after every year.
• Excel sheets shall also be re-validated if:

1. Any change in the formula.
2. Any change in the design/template of the Excel Sheet.
3. After re-installation of the software.

ABBREVIATIONS

SOP – Standard Operating Procedure

QC – Quality Control

QA – Quality Assurance

ATTACHMENTS

Attachment I: Validation of Excel Spreadsheet

Attachment II: Validated Excel Sheet Index

Attachment III: Table of Passwords of Spreadsheet

REVISION HISTORY

Nil

ALSO READ: SOP for Analytical Method Validation