What is the CSV? What is automation testing?

Question

Accepted Answer

CSV stands for Computer System Validation. Automation testing is the use of software to execute tests.

CSV is a process of ensuring that a computer-based system meets its intended requirements and is compliant with regulatory standards.
Automation testing involves using software tools to run tests automatically, reducing the need for manual testing.
CSV and automation testing are often used together to ensure that computer systems are validated and tested thoroughly.
Examples of automation testing tools include Selenium, Appium, and TestComplete.

Accepted Answer

The GAMP (Good Automated Manufacturing Practice) guidelines provide a framework for ensuring that computerized systems used in pharmaceutical and healthcare industries are fit for their intended purpose, comply with regulatory requirements, and are properly validated. The guidelines cover various aspects such as risk management, documentation, testing, and maintenance.

"GxP" refers to various regulations and guidelines (e.g., GMP for Good Manufacturing Practice, GLP for Good Laboratory Practice, GCP for Good Clinical Practice) that govern various aspects of the pharmaceutical and healthcare industries.

"GxP Project related bugs" would refer to software defects or issues that arise during the development or implementation of computerized systems in compliance with GxP guidelines. These bugs could lead to failures in validation, data integrity issues, regulatory non-compliance, and potentially compromise patient safety. Examples of such bugs could include failures in data encryption, improper validation of software functions, or inadequate documentation of system changes. It's crucial to identify and address these bugs promptly to ensure the reliability and compliance of GxP systems.

What is the CSV? What is automation testing?

Cognizant Validation Engineer interview questions & answers