Description

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent, Annex 1,1, 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
• Impact of Electronic Systems…Clinical Investigations Q&A Guidance for Industry Oct 2024
• 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
• How to write a Data Privacy Statement.

Areas Covered in the Session:-

1. What does 21 CFR Part 11 mean 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 the 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

end.

Who Will Benefit:-

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