SQA Data Integrity and Electronic Records

Question 1

What does the acronym ALCOA stand for in the context of GLP data integrity?

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate

Answer

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the five core principles defining data integrity in GLP and regulated environments.

Question 2

Under 21 CFR Part 11, which of the following is a mandatory requirement for electronic signatures to be considered legally equivalent to handwritten signatures?

Accepted Answer

The signature must include the signer's full legal name, date, and the meaning of the signature

Answer

21 CFR Part 11 requires electronic signatures to contain the signer's printed name, the date and time signed, and the meaning (such as review or approval) to be legally equivalent to handwritten signatures.

Question 3

What is the primary purpose of an audit trail in electronic GLP records?

Accepted Answer

To provide a secure, computer-generated record of who accessed, created, modified, or deleted data and when

Answer

An audit trail is a secure, time-stamped, computer-generated record that tracks all access and changes to electronic data, ensuring traceability and accountability.

Question 4

Which FDA regulation specifically governs electronic records and electronic signatures in regulated research environments?

Accepted Answer

21 CFR Part 11

Answer

21 CFR Part 11 is the FDA regulation that establishes criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.

Question 5

In GLP data recording, what does 'contemporaneous' mean?

Accepted Answer

Data is recorded at the time the observation or activity is performed

Answer

Contemporaneous means data is recorded at the time the observation or action occurs, not reconstructed later from memory, which is a core GLP data integrity principle.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Data Integrity and Electronic Records