After an open call that went out earlier this year, Shane De Büchel, Sr Manager of Quality Assurance (Compliance & Systems) at KCAS, has been selected as one of roughly 50 members of the Society of Quality Assurance to collaborate in authoring an upcoming data integrity book (the full name of the book has not yet been decided). Specifically, Shane will serve as a source of information representing data including GLP, GCP or GMV, providing input on how to approach data integrity, data quality, and how the industry is moving. The final resource will serve as a guiding light going forward for electronic data within our industry.
The book will be published by the Society of Quality Assurance as a one-time publication, and should be available some time this fall (as always, if there is a revision necessary, there would be a new title and a new set of authors for that revision). SQA has created similar publications in the past that were not open to the public – instead, they served as sources of reference only for SQA members – but this one will be a publication open for anyone to purchase.
The publication will cover many aspects of data quality, data integrity, the application thereof, the regulations that control, influence, and set the rules for what makes up data quality and data integrity, how it applies from a paper quality management system, as well as electronic quality management system, and how all these elements apply, from drug discovery early phase, all the way through clinical and marketing, and even manufacturing and post manufacturing.
“A lot of the industry is finally coming into the 21st century; getting into electronic quality management systems and being able to properly capture the data quality (from what was a paper-based system into an electronic system). It will be important to make sure that they are starting with good data quality, then move into maintaining it through their data integrity, such that that data is robust, reliable, and repeatable.” ~ Shane De Büchel
The book is necessary, Shane says, because there has been a perceived bit of confusion related to the FDA’s 21 CFR, part 11 which instructs on how to validate a system. The FDA expects organizations to apply 21 CFR, part 28 to these instructions to meet good documentation practices, as well as different ICH and OACD, EPA, AMA, and other different regulatory bodies. This book is working to unify these approaches.
“This book will help people understand what is actually the meat and potatoes of the data integrity of the data quality. It will give them a starting point and some real life scenarios to work from so they can benefit from other people’s anecdotes versus having to stumble through it themselves.” ~ Shane De Büchel
Shane has been invited to take part in this because of a number of credentials related to GLP experience and over 10 years of CRO experience. The Society of Quality Assurance had over 120 applicants worldwide. They selected just over 50 authors to take part in the book. Once complete, there is an editing board that will review and edit the contributions as needed.
The Society of Quality Assurance has been around for well over 40 years. The Midwest chapter is the celebrating its 30th year in 2022, and they are considered a point of resource for the industry and they are highly recognized among other quality professionals for the GLP, GCP and GMP for pharmaceutical and biopharmaceutical design development.
If you would like to learn more about the Society of Quality Assurance or the resources they have provided in the past, please click here. If you would like to set up a time to speak directly with any of other bioanalytical specialists here at KCAS, please use the form below.