Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

In October we had a meeting with the FDA regarding spreadsheet use and spreadsheet validation.

Goals

On October 13th 2004 we had a meeting Dennis Cantellops, QA Manager for the US FDA San Juan District in Puerto Rico. Dennis is widely recognised as the FDA's foremost expert on spreadsheet use and spreadsheet validation.

The goals of the meeting were two-fold.

To learn from the FDA their requirements for spreadsheet validation and to explore their current initiatives.
To advise the FDA on the spreadsheet validation issues facing the industry as seen by ABB Process Solution

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

Download it here. (pdf - 313kb) and remember 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 multi user spreadsheet (i.e. a spreadsheet that is used multiple times, or by multiple users, such as a spreadsheet template). The following key points should be noted.

the document refers to the DaCS product. It states "spreadsheet applications should be protected with the safeguards identified in 21 CFR Part 11........The security, audit trails and true electronic signatures can be implemented by software and services such as what is available from the company Wimmer Systems".

the document refers to "the usefulness of software that audits the workbook file and generates validation documentation". This is what we have designed our new Spreadsheet Specification and Reporting Tool to do.

the document refers to "the components of validation documentation". This closely mirrors our own spreadsheet validation process. It correctly puts the focus on to validating each and every spreadsheet.

Our assessment of the document.

Overall the requirements of the LIB (Laboratory Information Bulletin) are practical and fully inclusive. Our only concern is over the detail and time requirements to execute it fully on a large inventory of spreadsheets. We would recommend a more streamlined approach and use of generic documentation and generic processes. This would of course be based on risk based assumptions to provide a complete yet pragmatic validation package for each and every spreadsheet.

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.

This document is still in draft form and the FDA have asked us to have a final review of the document before release. We expect the document to be released around the end of the year. This document refers to the use of single use spreadsheets (i.e. you open a blank spreadsheet, and generate data and formulas straight into a blank worksheet). It will discuss the requirements needed for these "single use" spreadsheets. It is an interesting topic and we look forward to its release.

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

The FDA have agreed to Beta test this tool for use. It provides a quick and easy way to generate spreadsheet specifications, and to report the content and calculations within a spreadsheet. Quick and easy to use for FDA and SOX requirements. It is a simplified and more specific version of the tool used with the FDA LIB document.

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. The most notable are.

Dr Panko. University of Hawaii. http://panko.cba.hawaii.edu

Kamalasen Rajalingham. Quality Control of spreadsheets. - External link (pdf - 110 kb) http://panko.cba.hawaii.edu/ssr/HICSS33/HICSS33-Rajal-SoftEngr.pdf




		FDA Meeting with www.spreadsheetvalidation.com

	In October we had a meeting with the FDA regarding spreadsheet use and spreadsheet validation. Goals On October 13th 2004 we had a meeting Dennis Cantellops, QA Manager for the US FDA San Juan District in Puerto Rico. Dennis is widely recognised as the FDA's foremost expert on spreadsheet use and spreadsheet validation. The goals of the meeting were two-fold. To learn from the FDA their requirements for spreadsheet validation and to explore their current initiatives. To advise the FDA on the spreadsheet validation issues facing the industry as seen by ABB Process Solution Discussion of the FDA's Laboratory Information Bulletin - Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory. Download it here. (pdf - 313kb) and remember 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 multi user spreadsheet (i.e. a spreadsheet that is used multiple times, or by multiple users, such as a spreadsheet template). The following key points should be noted. the document refers to the DaCS product. It states "spreadsheet applications should be protected with the safeguards identified in 21 CFR Part 11........The security, audit trails and true electronic signatures can be implemented by software and services such as what is available from the company Wimmer Systems". the document refers to "the usefulness of software that audits the workbook file and generates validation documentation". This is what we have designed our new Spreadsheet Specification and Reporting Tool to do. the document refers to "the components of validation documentation". This closely mirrors our own spreadsheet validation process. It correctly puts the focus on to validating each and every spreadsheet. Our assessment of the document. Overall the requirements of the LIB (Laboratory Information Bulletin) are practical and fully inclusive. Our only concern is over the detail and time requirements to execute it fully on a large inventory of spreadsheets. We would recommend a more streamlined approach and use of generic documentation and generic processes. This would of course be based on risk based assumptions to provide a complete yet pragmatic validation package for each and every spreadsheet. 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. This document is still in draft form and the FDA have asked us to have a final review of the document before release. We expect the document to be released around the end of the year. This document refers to the use of single use spreadsheets (i.e. you open a blank spreadsheet, and generate data and formulas straight into a blank worksheet). It will discuss the requirements needed for these "single use" spreadsheets. It is an interesting topic and we look forward to its release. Discussion of the ABB Spreadsheet Specification and Reporting Tool for Microsoft® Excel. The FDA have agreed to Beta test this tool for use. It provides a quick and easy way to generate spreadsheet specifications, and to report the content and calculations within a spreadsheet. Quick and easy to use for FDA and SOX requirements. It is a simplified and more specific version of the tool used with the FDA LIB document. 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. The most notable are. Dr Panko. University of Hawaii. http://panko.cba.hawaii.edu Kamalasen Rajalingham. Quality Control of spreadsheets. - External link (pdf - 110 kb) http://panko.cba.hawaii.edu/ssr/HICSS33/HICSS33-Rajal-SoftEngr.pdf