Keynote Presentation
Are Spreadsheets a Fast Track to Regulatory Non-Compliance?
Presenter: Bob McDowall, director at R D McDowall Limited
An analytical chemist with over 45 years’ experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. Bob has been involved with automating analytical laboratories since 1980 and was an early implementer of a Laboratory Information Management System (LIMS) and the experience gained allowed him to edit the first book on the subject in 1988. Bob was presented with the 1997 LIMS Award by the LIMS Institute for advances in the subject and teaching. He was a co-author of the current version of USP <1058> on Analytical Instrument Qualification (AIQ).
Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and in 2019 published his book on Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories.
Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals. He is also involved in the GAMP Data Integrity Special Interest Group and is a contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity and the Good Practice Guides on Data Integrity - Key Concepts (2018) and Data Integrity by Design (2020).
Abstract
Chromatography Data Systems (CDS) have been at the heart of many data falsification and poor data management practices found in many FDA warning letters since the Able Laboratories fraud case in 2005.
Although current CDS applications have the ability to automate the chromatographic phase of an analysis through incorporation of calculations into an electronic workflow and review and approve results using electronic signatures, many laboratories use spreadsheets for post run calculations.
Apart from creating expensive electronic rulers, it opens the laboratory to inefficient working practices and the use of multiple hybrid systems which are a transcription checking nightmare. Using a case study aggregated from several laboratories the problems with using spreadsheets for post run calculations will be highlighted.
This will be contracted with an electronic process after elimination of spreadsheets to see the business and regulatory benefits that can be obtained from using a CDS fully.
R D McDowall Limited is a UK based company offering consulting, computerised system validation, data integrity assessments, auditing, training and writing services to clients working in or suppling to GXP regulated organisations and laboratories.