Can I read FDA Guidance on Computerized Systems on EtoBox?
FDA Guidance on Computerized Systems by x7w34T is a document available to read on EtoBox.
What is FDA Guidance on Computerized Systems about?
This document from the FDA provides guidance for sponsors, clinical researchers, and IRBs on the use of computerized systems in clinical investigations. It recommends that electronic source data and documentation meet the same standards of quality as paper records and comply with applicable regulations. It also supplements previous FDA guidance on electronic records and signatures to clarify how these apply to source data generated at clinical sites. The guidance aims to help ensure the reliability, quality
- Author
- x7w34T
- Language
- EN