Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR

Description

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 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.

LEARNING OBJECTIVES:

• Which data and systems are subject to Part 11 and Annex 11

• How to write a Data Privacy Statement