ABSTRACT
Over the past 25 years, data collection, recording, analysis, reporting, and regulatory
submissions have become greatly dependent on electronic computerized systems. Regulatory
agencies worldwide have begun accepting submissions electronically, even allowing these
applications being signed off electronically. This change in the traditional paper trail system
requires significant changes to data handling and greater emphasis on validating the regulatory
submissions. In laboratories conducting bioequivalence (BE) studies, the following instances
arise where validation of computer systems is required:
1. Record keeping systems including patient databases.
