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

Auditable, Legible, Complete, Original, Authorized

Answer

Attributable, Licensed, Contemporaneous, Official, Accurate

Answer

Auditable, Legible, Contemporaneous, Official, Authorized

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

The signature must be witnessed by a second authorized person

Answer

The signature must be printed on paper within 24 hours

Answer

The signature must use biometric identification only

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

To summarize the final conclusions of a study for regulatory submission

Answer

To replace the need for paper-based raw data in GLP studies

Answer

To automatically validate software used in laboratory computer systems

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 58

Answer

40 CFR Part 792

Answer

21 CFR Part 211

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

Data is reviewed and approved within the same calendar month

Answer

Data is stored in the same electronic system as related records

Answer

Data is collected by the same individual who designed the study

Question 6

Which of the following scenarios constitutes a data integrity violation in a GLP study?

Accepted Answer

Pre-dating a laboratory notebook entry to match when the experiment was originally planned

Answer

Correcting an error in raw data with a single line-through, initials, date, and reason

Answer

Maintaining an audit trail for all changes to electronic records

Answer

Using validated software to collect and store instrument data

Question 7

Under GLP regulations, what is a 'true copy' of a record?

Accepted Answer

A verified, exact reproduction of an original record that preserves all content and meaning

Answer

A summary document created by the study director summarizing raw data

Answer

A photocopy that has been signed by the principal investigator

Answer

An electronic file exported from any instrument regardless of verification