Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

Excel and Spreadsheet Validation

Published Papers

David Harrison and David Howard of ABB have authored a mini series of papers on spreadsheet validation. All three papers have now been published in the Pharma IT journal and are available for download below.

"A Pragmatic Approach to the Validation of Excel Spreadsheets - Overview" Pharma IT Journal, Vol. 1 No.2 April 2007.

"A Pragmatic Approach to the Specification of Excel Spreadsheets" Pharma IT Journal, Vol. 1 No.3 Jul 2007.

"A Pragmatic Approach to the Testing of Excel Spreadsheets" Pharma IT Journal, Vol. 1 No.4 Nov 2007.

Spreadsheet Validation. Technical And Business Justifications For The Wimmer Systems DaCS™ Approach To Validating Spreadsheets. David Harrison. Senior Consultant. ABB Engineering Services. 29 March 2004.
Spreadsheet Validation.
Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11. Issue of Pharmaceutical Technology. Tuan T. Phan. January 2003. (External link, PDF).

Excel and 21 CFR Part 11. A Summary and Interpretation of the Guidance for Excel and Wimmer Systems DaCS™.David Harrison. Senior Consultant. ABB Engineering Services. 19 March 2003.

FDA's Laboratory Information Bulletin - Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory. Dennis Cantellops. US FDA. 5th July 2002.

Spreadsheet Quality Control. Quality Control in Spreadsheets. A Software Engineering Approach to Spreadsheet Development. Kamalasen Rajalingham, Universtity of Greenwich, UK. (External link (pdf)

Excel Related Warning Letters

There have been a number of FDA warning letters raised against spreadsheets. See a summary of those warning letters here or see the index of warning letters.

Food and Drug Administration Information

ABB Regulatory update

Find attached our consultancy regulatory update to give you the latest information on compliance and regulatory news in the Life Science industries. (pdf - 49kb)

The FDA has announced a public meeting to discuss the regulations on electronic records and electronic signatures in 21 CFR part 11. FDA has begun to re-examine Part 11 as it applies to all FDA-regulated products. The public meeting was scheduled to be held on June 11, 2004 see here for latest news .

Part 11 Info

21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule. March, 1997

21 CFR Part 11. Guidance for Industry. A Summary and Interpretation of the Guidance Per Olsson, Principal Consultant. ABB Engineering Services. March 2003.

21 CFR Part 11. What Next for 21 CFR Part 11? Special Issue of Pharmaceutical Technology Europe. Per Olsson, Principal Consultant. ABB Engineering Services. March 2003.

Miscellaneous

Toward a Paperless Lab? Lab information management systems, electronic notebooks, and other applications help researchers maintain order in the lab. 24 Feb 2003 issue of The Scientist. Laura Bonetta.(External link, free registration required.)




		Articles of Interest

	Excel and Spreadsheet Validation Published Papers David Harrison and David Howard of ABB have authored a mini series of papers on spreadsheet validation. All three papers have now been published in the Pharma IT journal and are available for download below. "A Pragmatic Approach to the Validation of Excel Spreadsheets - Overview" Pharma IT Journal, Vol. 1 No.2 April 2007. "A Pragmatic Approach to the Specification of Excel Spreadsheets" Pharma IT Journal, Vol. 1 No.3 Jul 2007. "A Pragmatic Approach to the Testing of Excel Spreadsheets" Pharma IT Journal, Vol. 1 No.4 Nov 2007. Spreadsheet Validation. Technical And Business Justifications For The Wimmer Systems DaCS™ Approach To Validating Spreadsheets. David Harrison. Senior Consultant. ABB Engineering Services. 29 March 2004. Spreadsheet Validation. Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11. Issue of Pharmaceutical Technology. Tuan T. Phan. January 2003. (External link, PDF). Excel and 21 CFR Part 11. A Summary and Interpretation of the Guidance for Excel and Wimmer Systems DaCS™.David Harrison. Senior Consultant. ABB Engineering Services. 19 March 2003. FDA's Laboratory Information Bulletin - Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory. Dennis Cantellops. US FDA. 5th July 2002. Spreadsheet Quality Control. Quality Control in Spreadsheets. A Software Engineering Approach to Spreadsheet Development. Kamalasen Rajalingham, Universtity of Greenwich, UK. (External link (pdf) Excel Related Warning Letters There have been a number of FDA warning letters raised against spreadsheets. See a summary of those warning letters here or see the index of warning letters. Food and Drug Administration Information ABB Regulatory update Find attached our consultancy regulatory update to give you the latest information on compliance and regulatory news in the Life Science industries. (pdf - 49kb) The FDA has announced a public meeting to discuss the regulations on electronic records and electronic signatures in 21 CFR part 11. FDA has begun to re-examine Part 11 as it applies to all FDA-regulated products. The public meeting was scheduled to be held on June 11, 2004 see here for latest news . Part 11 Info 21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule. March, 1997 21 CFR Part 11. Guidance for Industry. A Summary and Interpretation of the Guidance Per Olsson, Principal Consultant. ABB Engineering Services. March 2003. 21 CFR Part 11. What Next for 21 CFR Part 11? Special Issue of Pharmaceutical Technology Europe. Per Olsson, Principal Consultant. ABB Engineering Services. March 2003. Miscellaneous Toward a Paperless Lab? Lab information management systems, electronic notebooks, and other applications help researchers maintain order in the lab. 24 Feb 2003 issue of The Scientist. Laura Bonetta.(External link, free registration required.)