Laboratory Information Management System (LIMS) MCQs With Answer

Laboratory Information Management System (LIMS) MCQs With Answer

A Laboratory Information Management System (LIMS) is software that manages samples, workflows, instruments, results and quality data in pharmaceutical labs. For B. Pharm students, understanding LIMS is essential for good laboratory practice, GLP/GMP compliance, data integrity (ALCOA+), sample tracking, instrument interfacing, electronic signatures and 21 CFR Part 11 requirements. LIMS streamlines accessioning, batch records, reagent and inventory control, audit trails, report generation and validation (IQ/OQ/PQ). This topic links theory with real-world lab operations, improving efficiency, documentation and regulatory readiness. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a LIMS in a pharmaceutical laboratory?

• To replace laboratory staff with robots
• To manage samples, workflows, instruments and data for quality and traceability
• To manufacture pharmaceutical products
• To perform chemical synthesis automatically

Correct Answer: To manage samples, workflows, instruments and data for quality and traceability

Q2. Which regulatory requirement is most commonly associated with electronic records and signatures in LIMS?

• ICH Q3
• 21 CFR Part 11
• Good Distribution Practice (GDP)
• Environmental Protection Act

Correct Answer: 21 CFR Part 11

Q3. Which of the following best describes “accessioning” in LIMS?

• Assigning storage temperature to reagents
• Logging and assigning a unique identifier to a received sample
• Validating instrument performance
• Generating final regulatory reports

Correct Answer: Logging and assigning a unique identifier to a received sample

Q4. What does IQ/OQ/PQ validation stand for in LIMS implementation?

• Installation, Operational, Performance Qualification
• Integration, Optimization, Production Qualification
• Installation, Optimization, Protocol Qualification
• Interface, Operational, Performance Quality

Correct Answer: Installation, Operational, Performance Qualification

Q5. Which module in LIMS is primarily responsible for tracking reagents and consumables?

• Audit trail module
• Inventory or reagent management module
• Electronic signature module
• Reporting module

Correct Answer: Inventory or reagent management module

Q6. ALCOA+ principles relate to which aspect of LIMS-managed data?

• User interface design
• Data integrity: Attributable, Legible, Contemporaneous, Original, Accurate plus additional attributes
• Network security protocols
• Instrument calibration schedules

Correct Answer: Data integrity: Attributable, Legible, Contemporaneous, Original, Accurate plus additional attributes

Q7. Which feature allows LIMS to capture raw instrument output automatically?

• Manual transcription
• Instrument integration or interfacing (e.g., via APIs, drivers)
• Paper logbooks
• Physical sample labels

Correct Answer: Instrument integration or interfacing (e.g., via APIs, drivers)

Q8. In the LIMS context, what is an audit trail used for?

• Storing unused reagents
• Recording who did what, when and why to maintain traceability
• Scheduling instrument maintenance
• Designing analytical methods

Correct Answer: Recording who did what, when and why to maintain traceability

Q9. Which of these is a key advantage of configuring LIMS workflows instead of customizing code?

• Higher long-term maintenance costs
• Easier upgrades and regulatory validation
• Increased dependency on vendor for every small change
• Complete removal of validation needs

Correct Answer: Easier upgrades and regulatory validation

Q10. Which LIMS function supports environmental monitoring in a pharmaceutical facility?

• Sample accessioning only
• Environmental data capture, trending and alarm management
• Payroll processing
• Clinical trial randomization

Correct Answer: Environmental data capture, trending and alarm management

Q11. What distinguishes a LIMS from an Electronic Laboratory Notebook (ELN)?

• LIMS focuses on sample, workflow and data management; ELN focuses on researchers’ experimental notes and protocols
• ELN is only for clinical data while LIMS is only for chemistry
• LIMS cannot store analytical results
• ELN manages instrument drivers while LIMS does not

Correct Answer: LIMS focuses on sample, workflow and data management; ELN focuses on researchers’ experimental notes and protocols

Q12. Which of these is a common identifier used by LIMS to ensure sample traceability?

• Generic lab name
• Unique sample ID or barcode
• Analyst’s social media handle
• Instrument serial number only

Correct Answer: Unique sample ID or barcode

Q13. How does LIMS help comply with Good Laboratory Practice (GLP)?

• By eliminating the need for SOPs
• By documenting sample history, results, audit trails and controlled access
• By performing chemical analyses automatically
• By replacing regulatory inspections

Correct Answer: By documenting sample history, results, audit trails and controlled access

Q14. Which capability is important for LIMS to support batch release testing in pharma?

• Automated calculation and specification checking with pass/fail flags
• Only storing handwritten reports
• Random deletion of old results
• Managing cafeteria meal plans

Correct Answer: Automated calculation and specification checking with pass/fail flags

Q15. What is a “chain of custody” in LIMS terms?

• A feature for exporting data to spreadsheets
• A record documenting transfer, custody and handling of samples through the workflow
• A module for financial auditing
• Label printing for safety data sheets

Correct Answer: A record documenting transfer, custody and handling of samples through the workflow

Q16. Which security feature is essential in LIMS to control user actions?

• Open anonymous access
• Role-based access control and permissions
• Unlimited administrator rights for all users
• Only physical locks on doors

Correct Answer: Role-based access control and permissions

Q17. In LIMS validation, which document demonstrates that the system meets user requirements?

• Disposal certificate
• User Requirements Specification (URS) and its verification through tests
• Inventory ledger
• Generic marketing brochure

Correct Answer: User Requirements Specification (URS) and its verification through tests

Q18. Which data integrity concept ensures that records are created at the time the activity occurs?

• Backdating
• Contemporaneous recording
• Offline transcription
• Archival only

Correct Answer: Contemporaneous recording

Q19. What role do APIs play in modern LIMS architectures?

• They allow integration with instruments, ERP, ELN and third-party software
• They are used only for printing labels
• They prevent any external communication
• They replace the need for data validation

Correct Answer: They allow integration with instruments, ERP, ELN and third-party software

Q20. Which reporting capability is most valuable for regulatory submissions?

• Customizable, traceable reports with audit trail and electronic signatures
• Screenshots without metadata
• Handwritten summaries only
• Randomized charts with no source data

Correct Answer: Customizable, traceable reports with audit trail and electronic signatures

Q21. How does LIMS assist with instrument calibration and maintenance?

• By scheduling, documenting calibration events and linking maintenance records to instruments and results
• By automatically replacing parts
• By deleting old calibration data
• By limiting access to instruments entirely

Correct Answer: By scheduling, documenting calibration events and linking maintenance records to instruments and results

Q22. Which is a common sample disposition option in LIMS after testing?

• Retain, dispose, archive or transfer
• Only immediate disposal with no record
• Publish sample details publicly
• Send samples to competitors

Correct Answer: Retain, dispose, archive or transfer

Q23. For pharmaceutical labs, why is backup and disaster recovery planning in LIMS critical?

• Because data loss can impact product release, regulatory compliance and patient safety
• Because backups slow down reporting
• It is optional for compliance
• Only for marketing purposes

Correct Answer: Because data loss can impact product release, regulatory compliance and patient safety

Q24. Which standard or practice often influences LIMS data exchange in clinical contexts?

• HL7 or CDISC standards for clinical data interchange
• ISO food safety only
• Local traffic regulations
• Building codes

Correct Answer: HL7 or CDISC standards for clinical data interchange

Q25. What is the benefit of barcode labeling integrated with LIMS?

• Increases manual entry errors
• Improves sample identification, reduces transcription errors and speeds processing
• Removes the need for any SOPs
• Makes audit trails unnecessary

Correct Answer: Improves sample identification, reduces transcription errors and speeds processing

Q26. Which KPI might a pharmaceutical lab monitor via LIMS dashboards?

• Sample turnaround time, percent on-time release, and instrument uptime
• Number of coffee breaks
• Only the number of stored PDFs
• Personal email usage

Correct Answer: Sample turnaround time, percent on-time release, and instrument uptime

Q27. How does LIMS handle out-of-specification (OOS) results?

• Automatically deletes them
• Flags results, triggers investigations and documents investigations per SOP
• Sends results to social media
• Overwrites with passing values

Correct Answer: Flags results, triggers investigations and documents investigations per SOP

Q28. Which deployment option may offer faster adoption and lower upfront hardware cost for LIMS?

• On-premises only
• Cloud-hosted or SaaS LIMS
• Paper-based system
• Using a spreadsheet on a shared desktop only

Correct Answer: Cloud-hosted or SaaS LIMS

Q29. When customizing a LIMS, what is a major validation risk?

• Customization can increase complexity, making validation and upgrades harder
• Customization always eliminates compliance requirements
• Customization makes the system immune to bugs
• Customization reduces the need for user training

Correct Answer: Customization can increase complexity, making validation and upgrades harder

Q30. Which documentation is essential to maintain when using LIMS for regulated testing?

• SOPs, validation protocols and reports, user training records and audit trails
• Only informal notes on sticky pads
• Advertising brochures
• Unverified third-party blog posts

Correct Answer: SOPs, validation protocols and reports, user training records and audit trails

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com