This eLearning module covers the regulatory expectations and practice related to equipment logbooks.
|Who is it for||
This course covers fundamental GMP requirements related to documentation and is for all employees involved in GMP and supporting operations.
|Why it matters||
All major GMP guidelines including US FDA, EU GMP and Schedule M have clear requirements on logbook usage and recording of events. While proper recording can support data integrity in many ways, Improper use and event recording can lead to regulatory observations and warning letters. Adoption of simple processes in this module can save hassle and improve the organization’s GMP compliance.