Computer System Validation(CSV) Interview Questions Part-1
- What is computer system validation, and why is it crucial in regulated industries? Computer system validation ensures that a computer system complies with specific regulatory standards. Its importance in regulated industries lies in safeguarding data integrity, product quality, and patient safety.
- Which regulatory requirements and guidelines are commonly referenced for computer system validation? Regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 are frequently used as guidelines for computer system validation.
- What are the essential elements of a computer system validation plan? A comprehensive validation plan includes a project overview, scope, objectives, validation strategy, roles and responsibilities, validation tasks, acceptance criteria, and a project timeline.
- How do you assess the criticality of a computer system in regulated environments? The criticality of a computer system is evaluated by considering its impact on product quality, patient safety, and regulatory compliance in case of system failure.
- What is risk-based validation, and how does it affect computer system validation? Risk-based validation focuses on the most critical aspects of the system, prioritizing validation efforts based on the potential risks. This approach optimizes the allocation of validation resources.
- How do you maintain regulatory compliance for computer systems throughout their lifecycle? Compliance is maintained through regular audits, reviews, continuous validation activities, and effective change control processes.
- What distinguishes validation from qualification in the context of computer systems? Validation ensures that a system meets its intended purpose, while qualification verifies that a system is properly installed and functions as expected.
- What are common challenges in computer system validation, and how can they be overcome? Common challenges include evolving regulations, technological advancements, and limited resources. These can be addressed by staying informed of regulatory changes, using robust validation tools, and ensuring adequate resource allocation.
- How is data integrity maintained in computer systems? Data integrity is preserved through the implementation of controls such as data encryption, access management, audit trails, and backup systems.
- How do you manage deviations and non-conformances in computer system validation? Deviations and non-conformances are managed by identifying root causes, applying corrective and preventive actions, documenting the resolution, and obtaining approval from relevant stakeholders.
