Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

June 2005 saw the release of the FDA's Laboratory Information Bulletin - Spreadsheet Design, Verification and Validation, Use and Storage of Single-User Workbook files in the US FDA Laboratories. Dennis Cantellops, QA Manager for the US FDA San Juan District is widely recognised as the FDA's foremost expert on spreadsheet use and spreadsheet validation.

Discussion of the FDA's Laboratory Information Bulletin - Spreadsheet Design, Verification and Validation, Use and Storage of Single-User Workbook files in the US FDA Laboratories

Download it here. (pdf - 1.36MB). We don't charge you for access to this document like other "independent" sites.

This document provides a very detailed overview of what the FDA expect to see when you validate a single-user spreadsheet (i.e. a spreadsheet that is created and used by a single user for a one-off analysis. The following key points should be noted.

the document refers to the DaCS product. It states " another approach to use the single-user workbook file is to add extra security, such as audit trails, and true electronic signatures which can be implemented by software and services such as that available from the company Wimmer Systems".

the document refers to the ABB Spreadsheet Specification and Reporting Tool . It states " the ABB Spreadsheet Specification and Reporting Tool, can be used to audit the single-user workbook file templates during the testing and verification stages".

the document refers to this website, and we are delighted to have had the final review of this document prior to release.

Our assessment of the document.

We had final review of this document, and therefore we are happy with its content and the approaches highlighted in it. One thing to note is that the use of this type of spreadsheet is by no means as common as that of the use of multi-user spreadsheets, and our experience has shown that probably only 1 in 100 spreadsheets are used in the way.

DaCS is one of the few products that actually allows you to work with new single use spreadsheets. Within DaCS you can open a new blank workbook, and operate as you would in native Excel. You would of course be monitored in your activities, with audit trails occurring for user inputs and modifications.

Once completed, your single use spreadsheet can (if needed) be electronically signed within DaCS, removing the need for any paper output.

Overall the requirements of the LIB (Laboratory Information Bulletin) are practical and fully inclusive. The focus here is on verification of the data and formulas rather than validation. Validation is not necessary in a single use spreadsheet, instead you rely on verification of the data. This can be done manually by users, or electronically by DaCS.

From a security point of view these spreadsheets do require more consistent checking by users, as custom development occurs each time. The more customised a spreadsheet is, the greater the risks of error by the user.

FDA's Laboratory Information Bulletin - Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory.

For information on the LIB Part 1, see here.

Discussion of the ABB Spreadsheet Specification and Reporting Tool for Microsoft® Excel.

The FDA have been involved in the Beta test of this tool. It provides a quick and easy way to generate spreadsheet specifications, and to report the content and calculations within a spreadsheet. Its ideal for single user spreadsheets and recommend by the FDA in the LIB Part 2 paper. Quick and easy to use for FDA and SOX requirements.

Discussion of new links and sources of information for Microsoft® Excel.

Dennis advised us on a number of excellent sources of information for Excel issues. These have been added to our Links Page.




		FDA LIB - Spreadsheet Design, Verification and Validation - Part 2.

	June 2005 saw the release of the FDA's Laboratory Information Bulletin - Spreadsheet Design, Verification and Validation, Use and Storage of Single-User Workbook files in the US FDA Laboratories. Dennis Cantellops, QA Manager for the US FDA San Juan District is widely recognised as the FDA's foremost expert on spreadsheet use and spreadsheet validation. Discussion of the FDA's Laboratory Information Bulletin - Spreadsheet Design, Verification and Validation, Use and Storage of Single-User Workbook files in the US FDA Laboratories Download it here. (pdf - 1.36MB). We don't charge you for access to this document like other "independent" sites. This document provides a very detailed overview of what the FDA expect to see when you validate a single-user spreadsheet (i.e. a spreadsheet that is created and used by a single user for a one-off analysis. The following key points should be noted. the document refers to the DaCS product. It states " another approach to use the single-user workbook file is to add extra security, such as audit trails, and true electronic signatures which can be implemented by software and services such as that available from the company Wimmer Systems". the document refers to the ABB Spreadsheet Specification and Reporting Tool . It states " the ABB Spreadsheet Specification and Reporting Tool, can be used to audit the single-user workbook file templates during the testing and verification stages". the document refers to this website, and we are delighted to have had the final review of this document prior to release. Our assessment of the document. We had final review of this document, and therefore we are happy with its content and the approaches highlighted in it. One thing to note is that the use of this type of spreadsheet is by no means as common as that of the use of multi-user spreadsheets, and our experience has shown that probably only 1 in 100 spreadsheets are used in the way. DaCS is one of the few products that actually allows you to work with new single use spreadsheets. Within DaCS you can open a new blank workbook, and operate as you would in native Excel. You would of course be monitored in your activities, with audit trails occurring for user inputs and modifications. Once completed, your single use spreadsheet can (if needed) be electronically signed within DaCS, removing the need for any paper output. Overall the requirements of the LIB (Laboratory Information Bulletin) are practical and fully inclusive. The focus here is on verification of the data and formulas rather than validation. Validation is not necessary in a single use spreadsheet, instead you rely on verification of the data. This can be done manually by users, or electronically by DaCS. From a security point of view these spreadsheets do require more consistent checking by users, as custom development occurs each time. The more customised a spreadsheet is, the greater the risks of error by the user. FDA's Laboratory Information Bulletin - Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory. For information on the LIB Part 1, see here. Discussion of the ABB Spreadsheet Specification and Reporting Tool for Microsoft® Excel. The FDA have been involved in the Beta test of this tool. It provides a quick and easy way to generate spreadsheet specifications, and to report the content and calculations within a spreadsheet. Its ideal for single user spreadsheets and recommend by the FDA in the LIB Part 2 paper. Quick and easy to use for FDA and SOX requirements. Discussion of new links and sources of information for Microsoft® Excel. Dennis advised us on a number of excellent sources of information for Excel issues. These have been added to our Links Page.