Computer System Validation Engineer Interview Questions and Answers

Pre-requisites for Operation Qualification include approved design specifications, installation qualification, and successful completion of performance qualification.

• Approved design specifications must be in place before conducting Operation Qualification.

• Installation qualification must be completed to ensure the system is installed correctly.

• Performance qualification must be successfully completed before Operation Qualification.

• Documentation of all testing and results is nec...read more

Deliverables as per GAMP5 guidelines include validation plan, user requirements specification, functional specification, test protocols, and validation report.

• Validation plan outlines the approach, resources, and schedule for validation activities.

• User requirements specification details the functional and non-functional requirements of the system.

• Functional specification describes how the system will meet the user requirements.

• Test protocols outline the tests to be performed ...read more

Risk assessments are carried out by identifying potential hazards, analyzing the likelihood and severity of their impact, and implementing controls to mitigate risks.

• Identify potential hazards in the system or process

• Analyze the likelihood of the hazard occurring

• Assess the severity of the impact if the hazard occurs

• Implement controls to mitigate risks

• Document the risk assessment process and findings

ALCOA is a set of principles used in computer system validation to ensure data integrity.

• Attributable: Data should be attributable to the person who created, modified, or reviewed it.

• Legible: Data should be clear and readable.

• Contemporaneous: Data should be recorded at the time of observation.

• Original: Data should be the first recording of the information.

• Accurate: Data should be error-free and true to the original observation.

GxP assessment is a process of evaluating and ensuring compliance with regulations and guidelines in industries such as pharmaceuticals and healthcare.

• GxP refers to Good Practice regulations in industries such as pharmaceuticals, healthcare, and food.

• GxP assessment involves evaluating systems, processes, and documentation to ensure compliance with regulations.

• Examples of GxP regulations include Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).