2021 - 21 CFR Part 11 Compliance for SaaS/Cloud Applications

Day 01(9:00 AM - 3:00 PM PST)
Introduction to the FDA (1 hr)
How the regulations help your company to be successful
Which data and systems are subject to Part 11.
21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (3:30 hr)
What Part 11 means to you, not just what it says in the regulations
Avoid 483 and Warning Letters
Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, and validation documentation
How SaaS/cloud computing changes qualification and validation
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures
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.
The Five Keys to COTS Computer System Validation (30 Min)
The Who, What, Where, When, and Why of CSV
The Validation Team (30 Min)
How to select team members
How to facilitate a validation project
Day 02(9:00 AM - 3:00 PM PST)
Ten-Step Process for COTS Risk-Based Computer System Validation (1:30 hr)
Learn which documents the FDA expects to audit.
How to use the risk-based validation approach to lower costs.
How to link requirements, specifications, risk management, and testing.
Document a computer system validation project using easy to understand fill-in-the-blank templates.
Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
How to Write Requirements and Specifications (30 Min)
Workshop for writing requirements and then expanding them for specifications
How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
Software Testing (1 hr)
Reduce testing by writing test cases that trace to elements of risk management.
How to write efficient test cases
How to write a Data Privacy Statement (30 Min)
How to meet the requirements of the EU GDPR
Purchasing COTS Software (30 Min)
How to purchase COTS software and evaluate software vendors
Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
How to save money
How to increase quality
How to increase compliance with less documentation