This training session describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
The impact of the pandemic may result in a change in the way we live in future; so understanding the capabilities, technology and opportunities on virtual possibilities of conducting clinical trials by ensuring the Design, Conduct, Monitoring and Analysis enables adapting to this paradigm. It thus is a great opportunity for all to be part of this SDE to add to our knowledge as clinical research professionals.