$Data Integrity & Privacy Compliance with 21 CFR Part 11 SaaS\/Cloud, EU GDPR$

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance 21 CFR Part 11& Annex 11 SaaS/Cloud
About this Event

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 the 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
What the regulations mean, not just what they say
Avoid 483 and Warning Letters
Requirements for local, SaaS, and cloud hosting
Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
How to use electronic signatures, ensure data integrity, and protect intellectual property
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software
Reduce validation resources by using easy-to-understand fill-in-the-blank validation documents.

Agenda:-

What 21 CFR Part 11 means today
- Purpose of Part 11
What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
Security standards
- Roles
- Usernames and passwords
- Restrictions and logs
Data transfer standards
- Deleting data
- Encryption
Audit trail standards
- Types of data
- High-risk systems
Electronic approval standards
- Electronic signatures
- Single sign-on
- Replacing paper with electronic forms
Infrastructure qualification
- How to efficiently document qualifications
Validation
- Software validation for vendors
- Computer system validation for users
- Fill-in-the-blank templates
- Change control re-validation
SaaS/Cloud hosting
- Responsibilities for the software vendor and hosting provider
- Evaluation criteria
- Hosting Requirements
SOPs
- IT, QA, validation
- Software development
Annex 11
- Comparison with Part 11
EU GDPR
- Data Privacy Statement