Computer Software Assurance: Use Industry Standards To Be Efficient and Compliant
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Speaker : DAVID NETTLETON
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When : Friday, September 26, 2025
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Time : 01 : 00 PM EST
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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.
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud-hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.
Learning Objectives
- Which data and systems are subject to Part 11 and Annex 11
- Computer Software Assurance impact on risk-based approach
- Impact of Electronic Systems…Clinical Investigations Q&A Guidance for Industry Oct 2024
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy-to-understand fill-in-the-blank validation documents
Areas Covered
1. What 21 CFR Part 11 mean today
- Purpose of Part 11
- Annex 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. Hardware is qualified
- IQ/OQ/PQ
8. GAMP categories
- No validation
- Software Validation (SV)
- Computer System Validation (CSV)
9. Expansion for industry categories
- Qualification of software utilities
- Hybrid Validation
- Statistical Analysis Program Validation
- Medical Device Software Validation
10. Evolution of COTS CSV
- Test-based
- Risk-based
11. Validation
- Software Validation for vendors
- Computer System Validation for users
- Change control re-validation
12. SaaS/Cloud hosting
- Responsibilities for the software vendor and the hosting provider
- Evaluation criteria
- Hosting requirements
13. How to implement compliance
- Software inventory
- Validation models and templates
Who Should Attend
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
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$160.00
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