Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to validate software employing Artificial Intelligence (AI). 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. Topics include security standards (roles, usernames, passwords, restrictions, and logs), data transfer standards (deleting data, encryption), audit trail standards, electronic approval standards (electronic signatures, single sign-on), infrastructure qualification, SaaS/Cloud hosting responsibilities, and EU GDPR data privacy requirements. Code: FDB3452