21 CFR Part 11 and Annex 11; what you need to know to pass the new Regulatory Inspections
About this Event

Overview

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.

Webinar Takeaways

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

Agenda

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
Data Privacy Statement
End

Who Will Benefit

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

Faculty David Nettleton

FDA Compliance Specialist

Computer System Validation

Roseville, California Area

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.