USV Validation Executive Interview Questions and Answers

Validation is the process of ensuring that something is accurate, reliable, and meets the required standards.

• Validation is a systematic and objective approach to assess the accuracy and reliability of data, processes, systems, or products.

• It involves comparing the results or outputs of a process or system with the expected or desired outcomes.

• Validation can be performed through various methods such as testing, inspecti...read more

The guidelines for equipment qualification vary depending on the industry and regulatory requirements.

• In the pharmaceutical industry, equipment qualification is guided by regulations such as Good Manufacturing Practices (GMP) and the International Conference on Harmonisation (ICH) guidelines.

• For medical devices, the guidelines may include the FDA's Quality System Regulation (QSR) and the ISO 13485 standard.

• In the food ...read more

The guideline referred for CSV is GAMP 5.

• CSV stands for Computer System Validation.

• GAMP 5 is a guideline developed by ISPE for the validation of automated systems.

• It provides a risk-based approach to validation and emphasizes on the importance of documentation.

• Other guidelines that may be referred to include FDA 21 CFR Part 11 and EU Annex 11.