Excel in the GxP-regulated Environment - Live Online Training

This Live Online Training aims to give participants a comprehensive overview of regulatory, technical and data integrity requirements for using Excel spreadsheets in a regulated GxP-environment. The translation of regulatory requirements into a lean and compliant approach will be demonstrated. Practical examples, exercises (including polling questions) and Q&A sessions ensure interaction and that all questions are answered.

Excel is widely used in laboratories, in production as well as in quality departments in both larger and smaller companies for GxP-relevant applications. The easy to use of spreadsheets allow making calculations, selections and colourful presentations in a very convenient way.
Quite often, numerous risks with regard to data integrity result from the diverse, flexible and sometimes very complex application possibilities. If Excel is used in a GxP-regulated environment for quality-relevant tasks, regulatory and data integrity requirements must be met. Files and calculations should be secured in such a way that formulas are not accidentally overwritten, templates are not changed or deleted and traceability of input, processing and output is trustworthy. Furthermore, accidental input of an inappropriate data type should be prevented.
However, controls are quite often inadequate and this may result in a compliance risk. Such Excel applications may easily come into focus in authority inspections.

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