What 21 CFR Part 11 means today
What does Part 11 mean?
Security standards
Data transfer standards
Audit trail standards
Electronic approval standards
Infrastructure qualification
Validation
SaaS/Cloud hosting
SOPs
Annex 11
EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). 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.