Computer System Validation(CSV) Interview questions Part-2
- How is a risk assessment for computer systems carried out? A risk assessment is performed by identifying potential threats, analyzing their likelihood and impact, and implementing strategies to mitigate risks to an acceptable level.
- How do you ensure compliance with electronic recordkeeping requirements for computer systems? Compliance is ensured by implementing controls that safeguard data security, integrity, authenticity, and retention in accordance with regulatory requirements.
- What documentation is essential for computer system validation? Key documentation includes the validation plan, system requirements specifications, design specifications, test protocols, validation reports, and user manuals.
- What is the process for validating software in computer systems? Software validation involves executing testing and verification activities, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- How do you validate the hardware used in computer systems? Hardware is validated by confirming that it meets required performance, reliability, and compatibility standards with software and other system components.
- How do you maintain the validated state of computer systems? The validated state is preserved through a lifecycle management process that includes periodic audits, reviews, and revalidation activities throughout the system’s operational life.
- How are cybersecurity risks handled during computer system validation? Cybersecurity risks are mitigated by implementing controls like firewalls, intrusion detection systems, and user authentication to prevent unauthorized access and data breaches.
- How do you ensure that computer systems comply with data privacy regulations? Compliance with data privacy laws is ensured by applying data encryption, access control, data anonymization, and masking techniques to protect sensitive and personal information.
- How do you validate off-the-shelf software used in computer systems? Off-the-shelf software is validated by reviewing vendor-supplied validation documentation, conducting vendor audits, and performing additional validation activities to ensure regulatory compliance.
- What is the process for validating computer systems that utilize cloud-based services? Cloud-based services are validated by reviewing the provider’s validation documentation, auditing the vendor, and performing supplementary validation to ensure the service complies with regulatory standards.
