Rohan Builders 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

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.

GAMP 5 is a set of guidelines for computer system validation in the pharmaceutical and healthcare industries.

• GAMP stands for Good Automated Manufacturing Practice.

• GAMP 5 provides a framework for risk-based approach to computer system validation.

• It outlines best practices for validation of automated systems in regulated industries.

• GAMP 5 emphasizes the importance of documentation, testing, and change control.

• Examples of GAMP 5 principles include validation planning, user requi...read more

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).

21 CFR Part 11 outlines requirements for electronic records and electronic signatures in FDA-regulated industries.

• Requires controls for electronic records and signatures to ensure authenticity, integrity, and confidentiality

• Specifies requirements for electronic signatures, including unique identifiers and password protections

• Mandates audit trails to track changes and ensure data integrity

• Requires validation of software and systems used to generate electronic records

• Applies to...read more