Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

The following represents an example project.

Validation needs to be performed for every GxP critical spreadsheet. You may have a range of spreadsheets in your inventory that require validation. Throughout this example we will use assume 20 spreadsheets, a representative figure for a small site.
It is the spreadsheet validation component of the project that is the most time-consuming. We estimate that approximately 80% of resource effort will be on spreadsheet validation and typically less than 20% on validating a 3rd party package (DaCS™ in this situation).
Once the process is in place, it is likely that each spreadsheet will require 10 days** to validate in “native” Excel.

**N.B. This figure, and those below, ares based on our experience of client-developed approaches; we have seen approaches that are 25% of these figures, but also others that are 200% of these figures. The figures provided represent a mean value. Please feel free to contact us to discuss how your approach measures up. We are always open for new ideas. Please remember the example figures given are for a straightforward spreadsheet, with approximately 4 worksheets, and 100 formulas. Every spreadsheet is different and you will have to bear that in mind as you read. Please also remember the figures given are for total workload, including full completion of all deliverables.

The basic process would be

Spreadsheet reformat,

Spreadsheet informal test,

Spreadsheet specification,

Spreadsheet protocol,

Install Spreadsheet,

Test Spreadsheet,

SOP for Spreadsheet.

DaCS™ removes many of the difficult validation concerns (security, audit trail etc.) you would have with most spreadsheets, and as a result when you validate a spreadsheet in DaCS™, each spreadsheet takes less effort than one that is in “native” Excel. As an estimate it is likely that each DaCS™ spreadsheet will take 40% less time to validate (using the ABB process and deliverables) than a spreadsheet in “native” Excel . This reduced effort is obviously multiplied by however many spreadsheet you may have (20 in our example).

Therefore the estimated total effort for running your “home grown” spreadsheet validation process with “native” Excel is 220 days (including 20 days to formally develop the validation process).

The estimated total effort for running the ABB validation approach on 20 spreadsheets is approximately 120 days - a saving of 100 days.

The above example is covered in more detail in the business justification (PDF - 199KB) document.

To find out more see the Project presentation, available for viewing or download from here.

The conclusion.

Validating a spreadsheet can take anything from a couple of days up to 20 or 30 days depending upon the complexity and the approach you take. Choose a proven approach that keeps the effort to a minimum, but covers your compliance needs. There is a huge opportunity to save on resource effort by using a repeatable process - particularly if you need to validate a large number of spreadsheets.

If you would like to discuss your approach or see examples of our approach please see the case studies, or visit one of our conference events.

We are also happy to provide a comprehensive list of references upon request.




		Spreadsheet Validation Projects

	The following represents an example project. Validation needs to be performed for every GxP critical spreadsheet. You may have a range of spreadsheets in your inventory that require validation. Throughout this example we will use assume 20 spreadsheets, a representative figure for a small site. It is the spreadsheet validation component of the project that is the most time-consuming. We estimate that approximately 80% of resource effort will be on spreadsheet validation and typically less than 20% on validating a 3rd party package (DaCS™ in this situation). Once the process is in place, it is likely that each spreadsheet will require 10 days to validate in “native” Excel. N.B. This figure, and those below, ares based on our experience of client-developed approaches; we have seen approaches that are 25% of these figures, but also others that are 200% of these figures. The figures provided represent a mean value. Please feel free to contact us to discuss how your approach measures up. We are always open for new ideas. Please remember the example figures given are for a straightforward spreadsheet, with approximately 4 worksheets, and 100 formulas. Every spreadsheet is different and you will have to bear that in mind as you read. Please also remember the figures given are for total workload, including full completion of all deliverables. The basic process would be Spreadsheet reformat, Spreadsheet informal test, Spreadsheet specification, Spreadsheet protocol, Install Spreadsheet, Test Spreadsheet, SOP for Spreadsheet. DaCS™ removes many of the difficult validation concerns (security, audit trail etc.) you would have with most spreadsheets, and as a result when you validate a spreadsheet in DaCS™, each spreadsheet takes less effort than one that is in “native” Excel. As an estimate it is likely that each DaCS™ spreadsheet will take 40% less time to validate (using the ABB process and deliverables) than a spreadsheet in “native” Excel . This reduced effort is obviously multiplied by however many spreadsheet you may have (20 in our example). Therefore the estimated total effort for running your “home grown” spreadsheet validation process with “native” Excel is 220 days (including 20 days to formally develop the validation process). The estimated total effort for running the ABB validation approach on 20 spreadsheets is approximately 120 days - a saving of 100 days. The above example is covered in more detail in the business justification (PDF - 199KB) document. To find out more see the Project presentation, available for viewing or download from here. The conclusion. Validating a spreadsheet can take anything from a couple of days up to 20 or 30 days depending upon the complexity and the approach you take. Choose a proven approach that keeps the effort to a minimum, but covers your compliance needs. There is a huge opportunity to save on resource effort by using a repeatable process - particularly if you need to validate a large number of spreadsheets. If you would like to discuss your approach or see examples of our approach please see the case studies, or visit one of our conference events. We are also happy to provide a comprehensive list of references upon request.