CSA - Computer System Assurance - enhancement to CSV in GxP
Computer System Assurance, its core concept, and its integration in GAMP 5's second edition are of paramount importance
Lectures -7
Resources -2
Duration -39 mins
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Course Description
- 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.
Goals
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
Curriculum
Check out the detailed breakdown of what’s inside the course
Introduction
2 Lectures
- Introduction 01:44 01:44
- CSA background and history 07:51 07:51
Core concepts of CSA
5 Lectures
Instructor Details
Adrian Krzesniak
I am a seasoned Computer System Validation expert with over 15 years of extensive experience. My professional background encompasses a wide range of disciplines, including Information Technology, Software Development, Quality Assurance, and Software Quality Assurance. Throughout my career, I have had the privilege of imparting knowledge to and training hundreds of individuals in various facets of Computer System Validation.
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