SQA Data Integrity and Electronic Records 1 — Questions and Answers
Question 1: What does the acronym ALCOA stand for in the context of GLP data integrity?
- Attributable, Legible, Contemporaneous, Original, Accurate (Correct answer)
- Auditable, Legible, Complete, Original, Authorized
- Attributable, Licensed, Contemporaneous, Official, Accurate
- Auditable, Legible, Contemporaneous, Official, Authorized
Correct answer: Attributable, Legible, Contemporaneous, Original, Accurate
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?
- The signature must include the signer's full legal name, date, and the meaning of the signature (Correct answer)
- The signature must be witnessed by a second authorized person
- The signature must be printed on paper within 24 hours
- The signature must use biometric identification only
Correct answer: The signature must include the signer's full legal name, date, and the meaning of the signature
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?
- To provide a secure, computer-generated record of who accessed, created, modified, or deleted data and when (Correct answer)
- To summarize the final conclusions of a study for regulatory submission
- To replace the need for paper-based raw data in GLP studies
- To automatically validate software used in laboratory computer systems
Correct answer: To provide a secure, computer-generated record of who accessed, created, modified, or deleted data and when
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?
- 21 CFR Part 11 (Correct answer)
- 21 CFR Part 58
- 40 CFR Part 792
- 21 CFR Part 211
Correct answer: 21 CFR Part 11
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?
- Data is recorded at the time the observation or activity is performed (Correct answer)
- Data is reviewed and approved within the same calendar month
- Data is stored in the same electronic system as related records
- Data is collected by the same individual who designed the study
Correct answer: Data is recorded at the time the observation or activity is performed
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.
Question 6: Which of the following scenarios constitutes a data integrity violation in a GLP study?
- Pre-dating a laboratory notebook entry to match when the experiment was originally planned (Correct answer)
- Correcting an error in raw data with a single line-through, initials, date, and reason
- Maintaining an audit trail for all changes to electronic records
- Using validated software to collect and store instrument data
Correct answer: Pre-dating a laboratory notebook entry to match when the experiment was originally planned
Pre-dating records (backdating) is a data integrity violation because it falsifies the contemporaneous nature of the data, misrepresenting when the work was actually done.
Question 7: Under GLP regulations, what is a 'true copy' of a record?
- A verified, exact reproduction of an original record that preserves all content and meaning (Correct answer)
- A summary document created by the study director summarizing raw data
- A photocopy that has been signed by the principal investigator
- An electronic file exported from any instrument regardless of verification
Correct answer: A verified, exact reproduction of an original record that preserves all content and meaning
A true copy is a verified exact reproduction of an original record — it preserves all content and meaning and is confirmed by a qualified person to be identical to the original.
SQA Data Integrity and Electronic Records 1
What does the acronym ALCOA stand for in the context of GLP data integrity?