SQA Data Integrity and Electronic Records 2 — Questions and Answers
Question 1: The ALCOA+ framework expands the original ALCOA principles with additional attributes. Which of the following is part of ALCOA+?
- Complete, Consistent, Enduring, and Available (Correct answer)
- Certified, Controlled, Encrypted, and Authorized
- Compliant, Classified, Executable, and Archived
- Corroborated, Confirmed, Enhanced, and Audited
Correct answer: Complete, Consistent, Enduring, and Available
ALCOA+ adds Complete, Consistent, Enduring, and Available to the original five ALCOA principles, providing a more comprehensive framework for data integrity in regulated environments.
Question 2: According to GLP regulations (21 CFR Part 58), what is the minimum retention period for raw data and specimens from a non-clinical safety study submitted to the FDA?
- At least 5 years after the date the study is completed, discontinued, or terminated (Correct answer)
- At least 2 years after FDA approval of the related drug
- At least 10 years from the date the study begins
- At least 1 year after the submission of the final study report
Correct answer: At least 5 years after the date the study is completed, discontinued, or terminated
Under 21 CFR Part 58, GLP raw data must be retained for at least 5 years after the study is completed, discontinued, or terminated to support regulatory review.
Question 3: What is the primary goal of Computer System Validation (CSV) in a GLP laboratory?
- To demonstrate that a computer system consistently produces results meeting predetermined specifications and quality attributes (Correct answer)
- To ensure all laboratory staff are trained to use the software
- To back up all electronic records to a secondary server weekly
- To verify that the computer system connects to the internet securely
Correct answer: To demonstrate that a computer system consistently produces results meeting predetermined specifications and quality attributes
Computer System Validation demonstrates with documented evidence that a system consistently performs as intended, ensuring the reliability and integrity of electronic data it generates or manages.
Question 4: In the ALCOA framework, what does 'Complete' mean when applied to GLP data?
- All data, including original observations, deviations, and corrections, must be present without any omissions (Correct answer)
- A final study report has been written and signed by the study director
- All samples have been analyzed and results entered into the database
- The data has passed statistical analysis and quality review
Correct answer: All data, including original observations, deviations, and corrections, must be present without any omissions
Complete means the entire data record is present, including all original values, failed runs, deviations, and any corrections — no selective deletion or omission is permitted.
Question 5: What is metadata in the context of electronic GLP records?
- Data that describes the context, content, and structure of a primary record, such as time stamps, user IDs, and instrument settings (Correct answer)
- A summary table of key results included in the final study report
- The electronic signature applied to a completed data set
- A backup copy of original data stored in a separate archive
Correct answer: Data that describes the context, content, and structure of a primary record, such as time stamps, user IDs, and instrument settings
Metadata is contextual data — such as time stamps, operator IDs, instrument parameters, and audit trail entries — that describes and gives meaning to the primary data record.
Question 6: Under 21 CFR Part 11, before an organization can use electronic records in place of paper records, it must ensure which of the following?
- Systems are validated, access controls are in place, audit trails are active, and records can be accurately reproduced (Correct answer)
- All employees have completed a 40-hour computer training course
- Paper records are destroyed after electronic entry is completed
- The electronic system has received FDA pre-approval before use
Correct answer: Systems are validated, access controls are in place, audit trails are active, and records can be accurately reproduced
21 CFR Part 11 requires organizations to validate systems, implement access controls, maintain audit trails, and ensure records can be accurately retrieved and reproduced before using electronic records officially.
Question 7: In GLP studies, what is the key distinction between raw data and a final study report?
- Raw data is the original recorded observation or result; the final report is a summarized interpretation of all data presented to management or regulators (Correct answer)
- Raw data is only generated by automated instruments; the final report is handwritten by the study director
- Raw data must be destroyed once the final report is approved
- The final report is always more accurate than raw data due to editorial review
Correct answer: Raw data is the original recorded observation or result; the final report is a summarized interpretation of all data presented to management or regulators
Raw data is the primary, original record of an observation or measurement, while the final study report is an authorized interpretation and summary of all raw data collected during the study.
SQA Data Integrity and Electronic Records 2
The ALCOA+ framework expands the original ALCOA principles with additional attributes.
Which of the following is part of ALCOA+?