Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, 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.

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

Who Should Attend:

• GMP, GCP, GLP, regulatory professionals
• QA/QC Departments
• IT Departments
• Auditors
• Managers and directors
• Software vendors, hosting providers

Areas Covered in the Session :

1. What 21 CFR Part 11 means today

• Purpose of Part 11

2. What does Part 11 mean?

• SOPs
• System features
• Infrastructure qualification
• Validation

3. Security standards

• Roles
• Usernames and passwords
• Restrictions and logs

4. Data transfer standards

• Deleting data
• Encryption

5. Audit trail standards

• Types of data
• High risk systems

6. Electronic approval standards

• Electronic signatures
• Single sign-on
• Replacing paper with electronic forms

7. Infrastructure qualification

• How to efficiently document qualifications

8. Validation

• Software validation for vendors
• Computer system validation for users
• Fill-in-the-blank templates
• Change control re-validation

9. SaaS/Cloud hosting

• Responsibilities for software vendor and hosting provider
• Evaluation criteria
• Hosting requirements

10. SOPs

• IT, QA, validation
• Software development

11. Annex 11

• Comparison with Part 11

12. EU GDPR

• Data Privacy Statement