Data Integrity is currently a hot topic in the pharmaceutical industry and in the focus of health authority inspections.
A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory requirements are met through a consistent and rigorous validation process, this implies that the required controls are in place.
This 2-day training course provides practical guidance to understand the basics of data integrity and computer system validation and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.
On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.