Tips & Tricks for spreadsheet Validation

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Tips & Tricks for spreadsheet Validation

 A good road map and some tips and tricks can help you on your way through the rough landscape of spreadsheet validation.

  1. With all your experience, regulations, and guidelines in mind, develop a spreadsheet that includes all necessary requirements. Think of the following aspects:
    • Use of the spreadsheet must be restricted to the intended user. Place the template on a (server) location with access limited to selected users. Protect the spreadsheet with a password that allows users to open the spreadsheet as read-only.
    • You want to protect the spreadsheet against any undesired changes, so lock all cells within the spreadsheet (except the cells in which the user needs to give input). This way, the user cannot change cells with formulas, constants, labels etc.
    • Give the input cells a color to make the spreadsheet more clear and easier to understand for users.
    • Make use of drop-down menus or data entry limits to prevent entry mistakes.
    • Is the calculated result presented in the right way? Does it have the correct number of decimal places; is the unit of measure displayed?
    • You even can create an audit trail to log what has changed when using the spreadsheet to make it more compliant to the EU’s Annex 11 or FDA’s 21 CFR Part 11.
    • Like any application, implement a version number to the spreadsheet, which also comes in handy for change control.
    • When a user fills the validated spreadsheet template with data, the resulting spreadsheet file with data is an electronic record. Just like the template, make sure these files are stored on a (server) location with access and user rights limited to selected users.
  2. Prepare all validation documentation. Depending on the impact on Patient Safety, Product Quality, and Data Integrity and the complexity of the spreadsheet the GAMP guide can help you to find out what you need to do. Here you get the so called ‘GAMP software category’.
  3. During validation, manually verify the reliability of the spreadsheet. Verify the spreadsheet calculations by entering expected values and extreme values and verifying the behavior of the spreadsheet or comparing the data with already known data.
  4. Make sure all necessary supporting Standard Operating Procedures are present, such as procedures for Change and Configuration Management, Backup and Restore, and Archiving and Retrieval. Also provide Working Instructions for how to use the spreadsheet template for each type of user.
  5. After successful validation, celebrate your success and release the spreadsheet for use. Any changes should go via Change Control and the actions for revalidation can be determined based on a Risk Assessment.


 “Trust but Verify “ Ronald Reagan

 

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