Matrix Pharma Corp Computer System Validation Engineer Interview Questions, Process, and Tips

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 obs

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 Pract

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 Qua...read more