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useR! 2024
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8 - 11 July, 2024
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Tuesday, July 9 • 13:40 - 13:45
Adding the Missing Audit Trail to R - Magnus Mengelbier, Limelogic AB

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The R language is used more extensively across the Life Science industry for GxP workloads. The basic architecture of R makes it near impossible to add a generic audit trail method and mechanism for all users cases. Different strategies have been developed to provide some level of auditing, from logging conventions to file system audit utilities, but each has its drawbacks and lessons learned.

The ultimate goal is to provide an immutable audit trail compliant with ICH Good Clinical Practice, FDA 21 CFR Part 11 and EU Annex 11, regardless of the R environment. We consider different approaches to implement auditing functionality with R and how we can incorporate an audit trail functionality natively in R or with existing and available external tools and utilities that completely supports Life Science best practices, processes and standard procedures for analysis and reporting.
Speakers
avatar for Magnus Mengelbier

Magnus Mengelbier

Managing Director, Limelogic AB
Magnus is currently the Managing Director of Limelogic, a contributor, collaborator and independent consultant based in southern Sweden with over 25 years of experience in the Life Science industry. A keen advocate of simple programming approaches with a focus on GxP, compliance... Read More →

Tuesday July 9, 2024 13:40 - 13:45 CEST
Salzburg I
  R workflow + deployment + production, Lightning Talk
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