Pharma information management systems MCQs With Answer

Pharma information management systems (PIMS) are central to modern pharmaceutical operations, integrating data across drug development, manufacturing, quality assurance, regulatory submissions and pharmacovigilance. For B. Pharm students, mastering PIMS fundamentals—database architecture, Lab Information Management Systems (LIMS), electronic batch records, inventory management, eCTD submissions, 21 CFR Part 11 compliance, data integrity (ALCOA+) and validation (IQ/OQ/PQ)—is essential for career readiness. This topic bridges theoretical pharmaceutics and IT-driven workflows, showing how secure electronic records, access controls, audit trails and reporting support product quality and regulatory compliance. These MCQs explore core concepts, practical applications and standards to build deeper, job-ready understanding. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which module of a PIMS is primarily used to manage laboratory sample workflows and test results?

• Inventory management
• Lab Information Management System (LIMS)
• Electronic batch record system
• Pharmacovigilance database

Correct Answer: Lab Information Management System (LIMS)

Q2. Which regulatory requirement specifically addresses electronic records and electronic signatures for GxP compliance?

• ICH Q7
• 21 CFR Part 11
• ISO 9001
• GMP Annex 1

Correct Answer: 21 CFR Part 11

Q3. ALCOA+ is a set of principles for data integrity. What does ALCOA primarily emphasize?

• Availability and Longevity of data
• Attributable, Legible, Contemporaneous, Original, Accurate
• Access control, Logging, Confidentiality, Openness, Auditability
• Automation, Labelling, Compliance, Organisation, Access

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate

Q4. Which PIMS function helps manage raw material batches, lot traceability and expiry dates?

• Regulatory submission module
• Inventory and materials management
• Clinical trial management
• Pharmacovigilance case processing

Correct Answer: Inventory and materials management

Q5. IQ, OQ and PQ are steps in validation. What does OQ verify?

• Installation of hardware and software
• Operational performance against specifications
• Long-term process stability
• User training completeness

Correct Answer: Operational performance against specifications

Q6. eCTD is an electronic format used for regulatory submissions. What does eCTD stand for?

• electronic Clinical Trial Data
• electronic Common Technical Document
• electronic Compliance and Testing Document
• electronic Core Therapeutic Dossier

Correct Answer: electronic Common Technical Document

Q7. Which component of PIMS enforces role-based access and ensures users only perform authorized actions?

• Audit trail
• Access control system
• Data backup module
• Reporting engine

Correct Answer: Access control system

Q8. An audit trail in a computerized system is primarily used to:

• Reduce data storage costs
• Record who did what and when for data actions
• Automatically validate analytical methods
• Generate regulatory submissions

Correct Answer: Record who did what and when for data actions

Q9. Which PIMS integration improves traceability between production and quality control results?

• Integration between ERP and CRM
• Integration between MES and LIMS
• Integration between HR and payroll systems
• Integration between marketing and sales modules

Correct Answer: Integration between MES and LIMS

Q10. During data migration to a new PIMS, which activity is critical to ensure regulatory compliance?

• Disabling audit trails in the new system
• Performing data mapping and validation with reconciliation
• Only migrating master data and ignoring transactional data
• Allowing users to manually re-enter all legacy data

Correct Answer: Performing data mapping and validation with reconciliation

Q11. Which standard is most relevant for laboratory analytical method transfer and documentation within PIMS?

• ICH Q2(R1) for analytical method validation
• ISO 14001
• ICH Q10 for pharmaceutical quality system
• 21 CFR Part 820 for medical devices

Correct Answer: ICH Q2(R1) for analytical method validation

Q12. Which PIMS feature helps manage deviations, CAPA and change controls?

• Quality management module
• Inventory count module
• Payroll module
• Clinical data capture module

Correct Answer: Quality management module

Q13. What is the main purpose of electronic batch records (EBR) in pharmaceutical manufacturing?

• To file patents electronically
• To digitally capture manufacturing steps, parameters and approvals
• To manage clinical trial enrollment
• To monitor social media feedback

Correct Answer: To digitally capture manufacturing steps, parameters and approvals

Q14. Which practice ensures that electronic signatures are legally binding and secure?

• Using shared generic accounts for signatures
• Implementing unique user IDs, passwords and signature controls
• Disabling passwords to speed up workflow
• Signing on paper and scanning into the system

Correct Answer: Implementing unique user IDs, passwords and signature controls

Q15. Which term describes the systematic process of assessing risk to data integrity and system availability in PIMS?

• Data mirroring
• Risk assessment and management
• Content marketing
• Product lifecycle management

Correct Answer: Risk assessment and management

Q16. Which PIMS-related technology supports serialization and anti-counterfeiting across the supply chain?

• Barcode and unique identifier systems
• ERP payroll module
• Clinical endpoint adjudication
• Pharmacovigilance signal detection

Correct Answer: Barcode and unique identifier systems

Q17. Validation documentation that describes how the system was installed is called:

• Performance Qualification (PQ)
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• User Requirement Specification (URS)

Correct Answer: Installation Qualification (IQ)

Q18. Which data backup approach provides the fastest recovery with minimal data loss for critical PIMS?

• Annual full backup
• Off-site tape archive only
• Frequent incremental backups with off-site replication
• Single local copy on desktop

Correct Answer: Frequent incremental backups with off-site replication

Q19. Pharmacovigilance in PIMS primarily deals with:

• Manufacturing equipment calibration
• Detection, assessment and prevention of adverse drug reactions
• Inventory reorder point calculation
• Marketing authorization renewals only

Correct Answer: Detection, assessment and prevention of adverse drug reactions

Q20. Which practice is essential to maintain data integrity when users modify electronic records?

• Allow anonymous editing without logging
• Require justification, electronic signature and record of the change in audit trail
• Overwrite original records without trace
• Disable audit trail to improve performance

Correct Answer: Require justification, electronic signature and record of the change in audit trail

Q21. In a validated PIMS, who should approve changes to the system configuration?

• Any user with system access
• Authorized change control board or designated approvers
• External marketing agency
• Temporary contractors without documentation

Correct Answer: Authorized change control board or designated approvers

Q22. Which analytics capability in PIMS helps QC labs detect trending failures early?

• Descriptive dashboards and statistical process control charts
• Basic text editor
• Unstructured social media scraping
• Simple file storage without visualization

Correct Answer: Descriptive dashboards and statistical process control charts

Q23. Which of the following is a primary benefit of cloud-based PIMS compared to on-premise?

• Guaranteed elimination of all cyber risk
• Scalability, faster deployment and managed updates
• No need for regulatory compliance
• Offline-only access

Correct Answer: Scalability, faster deployment and managed updates

Q24. For PIMS validation, the User Requirements Specification (URS) should be:

• Vague to allow flexibility
• Detailed, testable and traceable to tests
• Written after system go-live only
• Confidential and not shared with validation team

Correct Answer: Detailed, testable and traceable to tests

Q25. Which PIMS feature ensures batch release decisions combine manufacturing and QC results?

• Automated batch review and electronic signatures
• Standalone spreadsheets saved on desktops
• Manual paper-based checklists only
• Marketing analytics dashboard

Correct Answer: Automated batch review and electronic signatures

Q26. Which approach best supports long-term archival and retrieval of regulatory submission files?

• Storing submissions in proprietary unreadable formats only
• Using standardized formats like eCTD with validated archival systems
• Deleting old submissions routinely
• Printing submissions and storing loose papers unindexed

Correct Answer: Using standardized formats like eCTD with validated archival systems

Q27. Which control minimizes insider threats and enforces separation of duties in PIMS?

• Shared admin accounts for convenience
• Role-based access control and segregation of duties
• Allowing all users full system privileges
• Removing password requirements

Correct Answer: Role-based access control and segregation of duties

Q28. What is the primary role of metadata in pharmaceutical data management?

• To store the drug product samples
• To describe data context, provenance and relationships for discoverability
• To replace raw data with summaries only
• To encrypt data without keys

Correct Answer: To describe data context, provenance and relationships for discoverability

Q29. Which validation evidence demonstrates that a PIMS consistently operates as intended in routine use?

• Uncontrolled user testimonials
• Performance Qualification (PQ) results under real-world conditions
• Only vendor marketing materials
• Installation pictures only

Correct Answer: Performance Qualification (PQ) results under real-world conditions

Q30. When selecting a PIMS vendor, which factor is most important for ensuring regulatory compliance?

• Vendor’s ability to provide validation deliverables, compliance references and support for 21 CFR Part 11
• Lowest initial purchase price regardless of features
• Vendor location only
• Number of social media followers

Correct Answer: Vendor’s ability to provide validation deliverables, compliance references and support for 21 CFR Part 11

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