System Validation Engineer Interview Questions and Answers

System security controls are measures implemented to protect systems from threats and vulnerabilities.

• Access Control: Ensures only authorized users can access systems (e.g., role-based access control).

• Encryption: Protects data by converting it into a secure format (e.g., AES encryption for sensitive data).

• Firewalls: Monitors and controls incoming and outgoing network traffic (e.g., hardware or software firewalls).

• Intrusion Detection Systems (IDS): Monitors network traffic for...read more

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

• Electronic records must be accurate, reliable, and consistent.

• Systems must have controls to ensure data integrity, such as audit trails.

• Users must be uniquely identified and authenticated before accessing records.

• Electronic signatures must be linked to their respective records and include the signer's name, date, and time.

• Records must be maintained in a secure environment to ...read more

Diagnostic refers to the process of identifying issues in a system through testing and analysis.

• Conduct tests to gather data on system performance and behavior.

• Use tools like oscilloscopes or logic analyzers to monitor signals.

• Analyze logs and error messages to pinpoint failures.

• Perform root cause analysis to determine underlying issues.

• Example: If a system fails to boot, check power supply and hardware connections.

Validation deliverables are essential documents and artifacts that ensure a system meets its requirements and functions correctly.

• Validation Plan: A document outlining the strategy for validation activities.

• Test Cases: Specific scenarios to validate system functionality, e.g., user login tests.

• Test Scripts: Automated scripts that execute test cases, ensuring repeatability.

• Validation Reports: Summaries of validation activities, including results and findings.

• Traceability Matri...read more

GAMP5 categorizes software based on complexity and validation needs, aiding compliance in regulated industries.

• Category 1: Infrastructure Software - Examples include operating systems and database management systems.

• Category 2: Non-configurable Software - Examples are commercial off-the-shelf (COTS) applications like Microsoft Office.

• Category 3: Configured Software - Examples include systems like LIMS or SCADA that can be configured but not extensively customized.

• Category 4: ...read more