In-Depth Testing of Computer Systems Regulated by FDA

Course Description

This CPE Webinar will focus on testing as a key element of Computer System Validation (CSV). 

The level of testing must reflect both the potential risk associated with the failure of the system to function properly. It must also be based on the systems’ classification in accordance with GAMP 5 and on a thorough risk assessment of what could happen if the system were to fail. A standard risk approach will be explained to incorporate into the testing to be done.

With the help of this CPE course, you will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements.

You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.

We will address all three phases of CSV testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each phase has specific requirements and the approach taken is critical in terms of the resources and time required.

In this CPE course, we will also discuss ways to minimize costs while assuring maximum compliance with FDA requirements for CSV.

Learning Objectives

• To determine the category of your system, based on GAMP 5 from ISPE.
• To determine the risks associated with the various ways your system may fail.
• To discuss the size, complexity, business criticality, category, and risk, and develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted.
• To analyze the FDA requirements for documentation of all testing activities.
• To inspect how to write a test protocol for each phase of testing: (1) Installation Qualification (IQ) (2) Operational Qualification (OQ) (3) Performance Qualification (PQ)
• To investigate how to develop test scripts and acceptance criteria.
• To analyze how to identify test discrepancies and distinguish the type:  test script errors, tester errors, system errors.
• To inspect how to document all testing and the summary reports.
• To investigate maintaining the system in a validated state, and keeping testing as a ‘living’ exercise that runs through the system life cycle.

Recommended For

• This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand In-Depth Testing of Computer Systems Regulated by FDA.

Who Should Attend?

Webinar Qualifies For

• 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
• 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
• 1.5 CPE Credit for Certified Information Security Manager (CISM)
• 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
• 1 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
• 1.5 CPE Credit for Information Technology Certified Associate (ITCA)

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