ABB Regulatory Updates
This Life Sciences Regulatory Update has been compiled from a survey of selected web-sites. The
reported news is centred on the validation and use of computerised systems under GMP conditions.
Life Sciences Regulatory Update - April 2009 Vol. 6 Issue 1
Life Sciences Regulatory Update - December 2008 Vol. 5 Issue 3
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.
Upcoming Conferences
News Archive
Finsbury Solutions Acquires Compassoft - February 2009. Finsbury Solutions adds DaCS to its product suite following this strategic acquistion. See here for more information.
New Website Launch - Microsoft Access. A sister website, dealing with MS-Access database compliance and validation, has recently been launched. Please visit www.accessvalidation.com for more details.
Webcast Events
Live demonstrations of the DaCS software are run on a regular basis. To participate in a web seminar you will need to contact ABB.
Recent Conferences
Recorded Conference - FDA News. Web/Audio Conference. "Spreadsheet Validation - Tools and Techniques to meet FDA Requirements ". Tuesday 25th August 2009. David Harrison.
Recorded Conference - FDA News. Audio Conference. "Spreadsheet Validation - Tools and Techniques to meet FDA Requirements ". Tuesday 30th September 2008. David Harrison.
FDA News. Audio Conference. "Spreadsheet Validation - Tools and Techniques to meet FDA Requirements ". Thursday 14th February 2008. David Harrison.
FDA News. Audio Conference. "Spreadsheet Validation Made Easy". Weds 11th October 2006. David Harrison.
FDA News. Audio Conference. "Spreadsheet Validation Made Easy". Weds 3rd May 2006. David Harrison.
2006 European Laboratory IT Compliance Week. Controlling and Validating Excel. Regulatory Compliance Workshop Group. London, UK. 7th February 2006. David Howard - ABB.
Institute of Validation Technology (IVT). Laboratory Controls and Compliance Workshop Conference. Spreadsheet and Database Validation, San Juan, Puerto Rico. Thurs 1st Dec 2005. Dennis Cantellops - FDA, David Harrison - ABB, Ty Mew - Ofni Systems, Michael Gesser - Allergan.
FDA News. Information Management Conference. "Spreadsheet Validation Made Easy". Washington DC. Fri 2nd Dec 2005. David Harrison.
FDA News. Audio Conference. "Spreadsheet Validation Made Easy". Weds 5th Oct 2005. David Harrison.
GAMP Forum Europe. Spreadsheet Validation. Newcastle, England. Thurs 6th Oct 2005. David Harrison.
ABB Engineering Services continue their industry presence as leading experts in the Pharmaceutical Industry. View the latest published articles.
