General Life Sciences Domain Knowledge
1. What is the significance of software testing in the life sciences domain?
Ensures compliance with regulatory standards like FDA, ISO, and GxP
while maintaining data integrity and patient safety.
2. What do you understand by GxP?
GxP refers to "Good Practice" guidelines like GMP (Good Manufacturing
Practice) and GLP (Good Laboratory Practice).
3. What is the role of validation in life sciences applications?
Validation ensures that a system meets its intended purpose and is
compliant with regulations (e.g., 21 CFR Part 11).
4. What is 21 CFR Part 11 compliance?
It's an FDA regulation that outlines the criteria for electronic records and
electronic signatures to be considered trustworthy and reliable.
5. What are the key challenges in testing life sciences applications?
Regulatory compliance, handling large datasets, ensuring accuracy, data
security, and traceability.
Testing Specific to Life Sciences
6. How do you ensure regulatory compliance in testing?
By mapping test cases to regulatory requirements, creating traceability
matrices, and maintaining detailed documentation.
7. What are IQ, OQ, and PQ in validation testing?
o IQ: Installation Qualification
o OQ: Operational Qualification
o PQ: Performance Qualification
8. How do you validate laboratory systems?
Test data accuracy, workflow automation, equipment calibration, and
integration with LIMS (Laboratory Information Management System).
9. Explain the importance of data integrity in the life sciences domain.
Ensures that data is accurate, complete, and consistent, meeting ALCOA
principles (Attributable, Legible, Contemporaneous, Original, Accurate).
10.What is a LIMS, and how do you test it?
Laboratory Information Management System (LIMS); tested for data
management, compliance, integration with instruments, and user access
controls.
Regulatory and Compliance Testing
11.What are the key features to test in a clinical trial management system
(CTMS)?
Patient data security, trial workflows, regulatory reporting, and
integration with other systems like EDC.
12.How do you test electronic health record (EHR) systems?
Validate patient data accuracy, role-based access, system integration,
and compliance with healthcare standards (e.g., HIPAA).
13.What is HIPAA, and why is it important in testing?
Health Insurance Portability and Accountability Act; ensures patient data
privacy and security in healthcare systems.
14.How do you test a system for 21 CFR Part 820 compliance?
Focus on device quality management, documentation, and defect
traceability.
15.What are some key considerations when testing a pharmacovigilance
system?
Adverse event reporting, data security, integration with other regulatory
databases, and compliance with ICH E2B standards.
Behavioral and Scenario-Based Questions
16.How do you ensure data security during testing in life sciences?
Ensure test environments replicate production, encrypt sensitive data,
and limit access based on roles.
17.How would you test a system upgrade in a validated environment?
Perform regression testing, validate all critical functionalities, and ensure
documentation for audit purposes.
18.Can you describe a challenging project where you had to meet strict
regulatory requirements?
(Provide a detailed example emphasizing adherence to regulatory
standards like FDA or ISO.)
19.How do you handle a situation where a developer disputes a defect
you reported?
Provide detailed evidence (logs, screenshots), ensure constructive
communication, and involve stakeholders if needed.
20.Describe a time when you contributed to a successful audit in a life
sciences project.
Share specific actions, such as organizing documentation or preparing
traceability matrices.
21.What steps would you take if a critical defect is found close to the
release date?
Assess the impact, prioritize its resolution, perform a risk analysis, and
communicate with stakeholders.
22.How do you ensure the accuracy of test results in a highly regulated
environment?
Cross-verify results, maintain traceability, and ensure peer reviews for
critical test cases.
23.What would you do if a test case is incomplete or unclear?
Clarify with stakeholders, review the requirements, and update the test
case for accuracy.
24.How do you manage competing priorities when multiple projects
require your attention?
Prioritize based on project deadlines, regulatory impact, and business
needs while communicating effectively.
25.Describe how you would onboard a new team member to a life
sciences QA project.
Provide training on regulatory standards, testing processes, and tools
used in the project.
Clinical Trial Basics Questions
26.What is a clinical trial, and why is it important?
A research study to test the safety and efficacy of drugs or treatments on
human participants.
27.What are the key phases of a clinical trial?
o Phase I: Safety and dosage
o Phase II: Efficacy and side effects
o Phase III: Large-scale testing
o Phase IV: Post-market surveillance
28.How do you test Clinical Trial Management Systems (CTMS)?
Validate trial workflows, ensure regulatory compliance, test integrations
with EDC systems, and validate reporting capabilities.
29.What is the difference between blinded and unblinded clinical trials?
o Blinded: Participants or researchers don’t know who receives
treatment.
o Unblinded: All parties know the treatment assignments.
30.What is ICH GCP, and why is it important?
International Council for Harmonisation of Good Clinical Practice ensures
ethical and scientific quality in clinical trials.
31.How do you test adverse event (AE) reporting in a clinical trial system?
Validate AE logging, automatic notifications, and reporting to regulatory
bodies.
32.What is a protocol deviation, and how do you handle it during testing?
Any divergence from the trial protocol; ensure systems flag deviations
accurately.
33.How do you test randomization in clinical trial software?
Validate algorithms for random assignment of participants and check
logs for accuracy.
34.What are some challenges in testing clinical trial systems?
Managing complex workflows, ensuring regulatory compliance, and
maintaining data accuracy for multi-site trials.
35.How do you test integrations between CTMS and other systems like
EDC or LIMS?
Validate data flow, synchronization, error handling, and compliance.
36.How do you test a drug-tracking application?
Validate supply chain workflows, barcode scanning, traceability, and
regulatory compliance.
37.How would you test a pharmacovigilance application for adverse drug
reporting?
Validate data accuracy, reporting workflows, and compliance with ICH
E2B standards.
38.What are your considerations when testing medical devices for
software validation?
Ensure compliance with ISO 13485, validate functionality, and test
against clinical use cases.
39.How do you ensure data integrity in life sciences testing?
Follow ALCOA principles, conduct audits, and validate system logs.
40.How do you prepare for an FDA audit of your QA processes?
Maintain traceable documentation, ensure proper validation records,
and conduct mock audits.
