Data Integrity:

Preparing your laboratory for a data integrity audit:
Gary Wright
Data Integrity:
Marc O’ Reagan

Each consumer expects that drugs they consume to be safe and effective. To ensure this, regulatory bodies such as the United States Food and Drug Administration (US FDA), the Irish HPRA have set regulatory standards, to assure proper design, monitoring and control of manufacturing processes and facilities for various systems. This is supported by underlying data to trace manufacturing processes, which can prove evidence that the drugs have been manufactured as per agreed protocols.