CSA - Computer System Assurance - enhancement to CSV in GxP

The goal of the course

• Learn about Computer System Assurance (CSA)

• Discover how CSA influences GAMP 5 2nd edition

• Explore risk assessment in CSA

• Familiarize yourself with new types of tests in CSA

• Explore critical thinking

Scope of the course

• Computer System Assurance background and history

• New Approach to Computer System Assurance

• Risk assessment in Computer System Assurance (CSA) and Computer System Validation (CSV)

• CSA test types

• Requirements and test case examples

• Computer System Assurance Versus Current Validation Approach

Computer System Assurance (CSA) in the context of GxP (Good Practice) refers to the specialized set of practices and processes implemented within highly regulated industries like pharmaceuticals, biotechnology, and healthcare to ensure that computer systems used in the development, manufacturing, testing, and distribution of products adhere to regulatory requirements and maintain data integrity. GxP encompasses various guidelines and regulations, such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP), among others.

Compliance with GxP regulations is critical for industries where product quality and patient safety are paramount. Failure to adhere to these regulations can result in severe consequences, including product recalls, regulatory fines, and damage to an organization's reputation. Computer System Assurance within GxP environments is a systematic approach to mitigate these risks and ensure the reliability and compliance of computer systems used in regulated processes.