SQA Data Integrity and Electronic Records 2

Question 1

The ALCOA+ framework expands the original ALCOA principles with additional attributes. Which of the following is part of ALCOA+?

Accepted Answer

Complete, Consistent, Enduring, and Available

Answer

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?

Accepted Answer

At least 5 years after the date the study is completed, discontinued, or terminated

Answer

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?

Accepted Answer

To demonstrate that a computer system consistently produces results meeting predetermined specifications and quality attributes

Answer

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?

Accepted Answer

All data, including original observations, deviations, and corrections, must be present without any omissions

Answer

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?

Accepted Answer

Data that describes the context, content, and structure of a primary record, such as time stamps, user IDs, and instrument settings

Answer

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.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Data Integrity and Electronic Records 2