Good Practices for Spreadsheet

 

Data Integrity App

Good Practices for Spreadsheet

When setting up a new spreadsheet, following the good practices below will reduce the risk of accidental modifications of the template and erroneous data input:

-  All calculating cells shall be locked (Format Cells > Protection > Locked) in order to protect cells containing calculations against unintended modification, except those used for data input.

- Cells used for data input can be identified by a specific colour.

-  Data validation rules (Data tab > Data Validation) can be applied to data input cells to prevent the introduction of aberrant values. Input messages and Error alert messages can be used to inform the end user of the expected data type and acceptable range.

Cells used for presenting the results of the calculations (output) can be identified by a specific color. When the results are tested against acceptance criteria it is recommended using conditional formatting (Home tab > Conditional Formatting) to highlight out-of- specifications results.

The name of the operator responsible for data entry, and the date and time of data entry should be recorded in dedicated input cells or the spreadsheet is printed, signed and dated after calculation.

-  File path, spreadsheet filename and MS Excel® version number can be displayed within the print  area  of  the  spreadsheet.  The  Excel  functions  ‘ =CELL("filename") ’ ‘=INFO("RELEASE")’ can be used to display the path, filename, active sheet and the version number of MS Excel® in use.

Password protection is recommended for all cells containing calculations (Review tab > Protect Sheet), with only the default options checked.

The same password can be used for all sheets and can be documented in the validation file. The sheet protection password should not be communicated to the end users.

After protecting each sheet, the workbook structure should also be password protected (Review tab > Protect Workbook). The same password can be used as the one for sheet protection.

An example of a spreadsheet used to calculate a vaccine titration is shown on the image below. From results obtained for a reference product (height measured at 4 concentrations), a calibration curve and its formula are provided. Both of them are needed to calculate the concentrations corresponding to the height measured for the tested vaccine.

Source; Validation of Computerised Systems Annex 1 – Validation of Excel Spreadsheets PA/PH/OMCL (08) 87 R6


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Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

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- Checklist for inspection

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- Useful SOP’s

- Stay Regulatory Compliant.

 

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