In-Depth Computer System Testing of Computer Systems Regulated by FDA

There are best practices associated with testing methodologies used in the FDA-regulated arena, and these can be used to develop a standard and consistent approach within a company. Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. Testing is a key aspect of computer system implementation, validation and all activities related to the system development life cycle (SDLC). As such, there are specific deliverables and key tasks that must be completed in accordance with FDA requirements.

There is an enormous body of documentation and information available related to computer system validation and testing that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available to assure a compliant testing process.

In this webinar will cover:

• GxP systems
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC)
• Testing in an FDA-regulated environment
• Test Planning, Execution, Discrepancy Resolution and Documentation
• Test Summary Report
• Unit and Integration Testing
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ; also User Acceptance Testing, or UAT)
• Test Scenarios, Test Cases and Test Scripts
• Positive and Negative Test Scenarios
• Stress and Boundary Testing
• Training (Users, Support)

The Learning Objectives of this Session are:

• Understand what qualifies a system for being regulated by FDA
• Understand how to use the Computer System Validation (CSV) methodology and System Development Life Cycle (SDLC) framework to validate a system
• Understand how to plan, execute and document the testing aspects of a computer system validation effort
• Learn how to determine roles and responsibilities associated with CSV testing
• Learn how to develop the test scenarios, cases and scripts for OQ and PQ
• Understand how to perform stress and boundary testing
• Understand how to incorporate positive and negative testing scenarios into your testing
• Understand the documentation required to support your validation testing effort
• Learn about potential pitfalls in testing that should be avoided
• Learn about the best practices for testing in an FDA-regulated environment

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.