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Excel Sheet Validation in Pharmaceuticals

Nowadays majority of Pharmaceutical industries are using automated software to maintain their data like SAP, LIMS etc. But still the use of Excel spreadsheet is valuable. 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 deliverable.  

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 sheet for individual tests, which can be common for all products.


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 validation of Excel worksheets to be used for analytical calculations in the Quality Control Laboratory at Company name.

RESPONSIBILITY
Validation Officer is responsible for design and validate the worksheet for different test.
QC Manager is responsible to ensure the accuracy of validation worksheet.
QA Manager shall be accountable for implementation of this SOP.

PROCEDURE
Control of Microsoft Excel worksheets:

  • Prepare separate calculation sheet for individual tests, which can be common for all products.
  • Protect the excel sheet except for the cells that need to be filled while calculating the results.
  • All worksheets used in the laboratory shall be validated with the help of IT department as per Attachment-I and approved by QA department.
  • 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 left corner with title “Company Name” in center as 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 material,
               FS for Finished product
               SS for Stability Product,
               IM for intermediate products,
               MS for miscellaneous samples,
               BBB represents unique incremental number.
               CC represents version no. starting from 00.

  • Master Excel spreadsheet shall be stored in a separate folder on the computer of administrator.
  • Only 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 letter.
  • The password of each workbook shall be maintained as per Attachment-III and will be kept by validation officer and QC manager.
  • The Excel worksheet shall be operational in “read only” format and user shall not be able to save any data on the sheet and user shall be authorized to take print only via “Ctrl+ P” command.
  • Addition or deletion of the any row/column in the worksheet impacting on the operation of the formulae shall be restricted.
Validation Procedure:
  • Availability of validated Spreadsheet.
        Acceptance criteria: Excel Sheet shall be available on a separate folder.
  • Wrong password.
An attempt shall be made to open the Excel workbook using a 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.)
  • 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 attach with validation document).
  • Addition or Deletion of row/column
An attempt shall be made to add or delete 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 spreadsheet validation document.)
  • Verification of calculations:
Each of the calculations shall be done by calculator as well as excel sheet and result shall be compared.
Results shall be rounded off up to 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 calculator shall be recorded.
Prior to verification of calculation, it should be ensuring that the formula to be used
 is as per 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 re validated after every year.
        Excel sheets shall also be re validated if:
        Any change in the formula.
        Any change in design/template of Excel Sheet.
        After re installation of 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 Password of Spreadsheet
 
Click an Image below is provided (as is) to download Annexure.
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