Healthcare 2021 - Computer System Validation (CSV) for FDA-Regulated Computers

Overview:
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA.
FDA's guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements, and creating a set of test scripts that will prove each requirement is met.