Management of electronic data in QA/QC MCQs With Answer

Introduction

Management of electronic data in QA/QC is a critical subject for M.Pharm students preparing for roles in pharmaceutical quality systems. This blog presents focused multiple-choice questions that cover principles such as data integrity (ALCOA+), regulatory requirements (21 CFR Part 11, EU Annex 11), system validation, audit trails, access controls, backup and archival strategies, electronic signatures, and procedural controls. Questions are designed to test applied knowledge required for implementing, monitoring, and auditing electronic data in laboratories and manufacturing quality systems. Practicing these MCQs will help students deepen understanding of technical, procedural, and regulatory aspects essential to ensure reliable, reproducible and compliant electronic records in pharmaceutical environments.

Q1. Which principle of data integrity emphasizes that data should be attributable, legible, contemporaneous, original and accurate?

• GAMP
• ALCOA
• CSV
• ISO 9001

Correct Answer: ALCOA

Q2. Which regulation specifically governs electronic records and electronic signatures for FDA-regulated industries?

• EU Annex 11
• ICH Q7
• 21 CFR Part 11
• GMP Annex 1

Correct Answer: 21 CFR Part 11

Q3. In the context of computerized system validation (CSV), what is the primary objective of User Requirements Specification (URS)?

• Describe the software code structure
• List the validation test scripts
• Define what the user needs the system to do
• Record daily system logs

Correct Answer: Define what the user needs the system to do

Q4. Which of the following is NOT part of ALCOA+ principles?

• Complete
• Original
• Accessible
• Confidential

Correct Answer: Confidential

Q5. What is the main purpose of an audit trail in an electronic quality system?

• To store backup copies
• To track and record changes to data and who made them
• To encrypt data at rest
• To prevent network access

Correct Answer: To track and record changes to data and who made them

Q6. According to EU Annex 11, what must be ensured for electronic signatures to be acceptable?

• They are printed on paper once a month
• They are unique to an individual and linked to their identity
• They are used only for internal memos
• They require no authentication

Correct Answer: They are unique to an individual and linked to their identity

Q7. Which control reduces risk of unauthorized changes in a Laboratory Information Management System (LIMS)?

• Open network access for all users
• Role-based access control with least privilege
• Using default vendor passwords indefinitely
• Storing raw data only on local analyst PCs

Correct Answer: Role-based access control with least privilege

Q8. What is the best practice for retention of electronic raw data in QA/QC labs?

• Retain only summary reports and delete raw data
• Retain original raw data with metadata and ensure secure archival
• Print raw data and destroy electronic copies immediately
• Keep raw data on analyst personal devices

Correct Answer: Retain original raw data with metadata and ensure secure archival

Q9. Which of the following is a key requirement when migrating legacy electronic data to a new system?

• Ignore metadata and only transfer PDF reports
• Validate migration to ensure completeness, integrity and traceability of data and metadata
• Migrate during peak production without testing
• Allow automatic deletion of source data after migration without verification

Correct Answer: Validate migration to ensure completeness, integrity and traceability of data and metadata

Q10. What is the role of the system owner in electronic data management?

• Write all laboratory SOPs alone
• Ensure system validation, data integrity, access control and ongoing maintenance
• Perform all routine backups personally
• Approve reagent purchases only

Correct Answer: Ensure system validation, data integrity, access control and ongoing maintenance

Q11. Which activity is essential to demonstrate suitability of a computerized system for its intended use?

• CSV including IQ/OQ/PQ
• Only vendor demonstrations
• Daily manual overrides
• Ad-hoc changes without documentation

Correct Answer: CSV including IQ/OQ/PQ

Q12. What does the acronym ‘CSV’ commonly stand for in pharmaceutical QA/QC contexts?

• Computer System Validation
• Critical Sample Volume
• Certified Standard Verification
• Controlled Storage Version

Correct Answer: Computer System Validation

Q13. Which of the following best describes ‘metadata’ in electronic laboratory records?

• The printed paper copies of reports
• Data about the data such as timestamps, instrument ID and operator
• A type of encryption algorithm
• Only the numerical results in a table

Correct Answer: Data about the data such as timestamps, instrument ID and operator

Q14. What is a key component of data backup strategy for QA/QC electronic systems?

• Single local backup on the same server
• Regularly scheduled, tested offsite/backups with verified restore procedures
• Backup only when convenient
• Never test restores to avoid risks

Correct Answer: Regularly scheduled, tested offsite/backups with verified restore procedures

Q15. In the event of an electronic data discrepancy, which step should be taken first?

• Immediately delete the record
• Perform a documented investigation to determine root cause and impact
• Ignore it if results look acceptable
• Change the data to match expectations without record

Correct Answer: Perform a documented investigation to determine root cause and impact

Q16. Which control ensures that only authorized personnel can electronically sign a document?

• Open guest accounts
• Multi-factor authentication tied to individual credentials
• Shared generic passwords
• Using analyst initials written on paper only

Correct Answer: Multi-factor authentication tied to individual credentials

Q17. Which one describes the ‘review and approval’ function in an electronic QC workflow?

• Automatic deletion of failed tests
• Formal electronic sign-off with audit trail proving reviewer identity and timestamp
• Allowing any user to mark results reviewed without logs
• Disabling audit trails during review

Correct Answer: Formal electronic sign-off with audit trail proving reviewer identity and timestamp

Q18. For laboratory instrument data captured electronically, what is considered best practice regarding raw chromatographic data?

• Store only peak tables and discard raw data files
• Retain original raw data files, associated metadata and processing methods
• Convert raw files to screenshots only
• Allow analysts to edit raw files without traceability

Correct Answer: Retain original raw data files, associated metadata and processing methods

Q19. What is the recommended action when changes to validated computerized systems are required?

• Implement changes immediately without assessment
• Use change control to assess impact, re-validate affected functions and document changes
• Allow vendor to change system without documentation
• Ignore regulatory expectations for revalidation

Correct Answer: Use change control to assess impact, re-validate affected functions and document changes

Q20. How should access to electronic data be logged to meet data integrity requirements?

• No logs are necessary if users are trusted
• Comprehensive audit logs recording user ID, action, date/time and reason for changes
• Logs that can be edited by any user
• Logs stored only on the user’s workstation

Correct Answer: Comprehensive audit logs recording user ID, action, date/time and reason for changes

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