Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
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 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
Overview of the webinar
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.
Who should attend?
- GMP, GCP, GLP, regulatory professionals
- QA/QC Departments
- IT Departments
- Auditors
- Managers and directors
- Software vendors, hosting providers
Why should you attend?
- 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
Faculty - Mr.David Nettleton
