Data integrity; 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, 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/Areas Covered:

• 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

 

1. 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

Who will benefit/Target Audience:

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

 

Industries: Pharmaceutical, medical device, biologics, food, cosmetics, FDA regulated companies, software vendors, SaaS providers, data centers

Questions for exam (optional)

1. For COTS software (vendor supplied) the users of the software are responsible for ensuring both software validation and computer system validation have been performed. True
2. Electronic signatures are required per Part 11. False
3. Compliance with Part 11 is based on industry standards not the text of the law itself. True
4. With SaaS/Cloud you no longer need to indicate major and minor software version. False
5. It is convenient and best to have your internet browser remember your password. False
6. An electronic signature must indicate user name, date, time, and meaning of the signature. True
7. SaaS/Cloud is better than local hosting because the vendor has already performed computer system validation. False
8. The most import document of any validation project contains the test cases. False
9. It is common and acceptable to share your password only with IT and software vendors. False
10. When a user is terminated their account should be deleted. False

Instructor Profile: Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.