Data Integrity Training

Computerized systems are widely used in pharmaceutical and biopharmaceutical environments to capture, analyze, store, and report data, and to control equipment and processes. Internal and external audits have consistently revealed gaps in validated computer controls and Data Integrity (DI), which has led to strong enforcement by global regulatory agencies such as FDA and EMA.
This two-day training provides a step-by-step understanding of DI methodology, regulatory expectations, and practical implementation techniques. Through real examples, case discussions, and interactive exercises, participants learn how to establish DI controls correctly the first time and build a reliable data management system that withstands inspection and audit scrutiny.