Revalidation spreadsheet

Spreadsheets can be a powerful tool to perform calculations and data evaluation more efficiently and to reduce errors in a cGXP environment. However, the possible problems and resources needed to develop, validate, and revalidate spreadsheets should not be underestimated. 

Since Excel is a powerful tool used widely for many different purposes with many options not all options can be discussed in this chapter. The focus of the chapter is on manually self-created spreadsheets for data calculation and checks against acceptance criteria (logical operations). Excel spreadsheets that are used with other electronic systems for automatic data or information entry, for further operations, or used as a view tool for databases are not within the scope of this chapter. Nevertheless, these types of spreadsheets are viewed as a normal spreadsheet with automatic entry, and validation, including validation of the interface, will be included to cover this item. In this chapter we provide guidance in validation and revalidation of Excel spreadsheets and information about managing validated spreadsheets. 

Change of software version(s). Changes in software version(s) require revalidation of the spreadsheet irrespective of whether a new version of Excel or Windows is used. It will be a business decision to stay with the old software version to avoid revalidation and save the resources required. In a large company, this will not be an easy decision. In this case, care should be taken to ensure the use of the appropriate software and spreadsheet version, especially if spreadsheets are used in a shared manner. In the case of a global rollout of new software, revalidation must take place prior to the rollout to ensure the use of validated spreadsheets starting on the day of the rollout. 

There are generally two options that can be followed for re validation. A spreadsheet developed and validated for Excel 97 could be opened with Excel 2000, revalidated and saved as an Excel 97 file. It can also be opened with Excel 2000, saved as an Excel 2000 file, and followed by revalidation. The decision as to how the spreadsheet is revalidated and its subsequent use must be documented. 

The degree of revalidation work to be done was determined during the impact analysis. Changes that impacted the configuration (hardware, software, and documentation) were recorded in a configuration log maintained within a spreadsheet. 

Regarding the failure to use fully validated computer spreadsheets to calculate analytical results for in-process and finished product testing (FDA-483, item 5), your response states fiiat old spreadsheets will be revalidated according to file proposed revisions to SOP 644 prior to being implemented into use. You identify that SOP 644 will not be revised until July 20, 2001. 

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