SQA MCQ 3

Question 1

Which ALCOA+ principle requires that electronic records cannot be altered without leaving a detectable audit trail?

Accepted Answer

Original

Answer

The 'Original' principle ensures that first-captured data is preserved and any changes are traceable, supporting data integrity.

Question 2

During a for-cause inspection, FDA investigators request all emails related to a batch failure. The QA manager should:

Accepted Answer

Consult legal counsel and provide requested records in accordance with applicable law

Answer

Responding to FDA inspection requests requires legal guidance to ensure compliance while protecting legitimate privileges.

Question 3

Which type of equipment qualification confirms that installed equipment operates within specified limits when connected to its utilities?

Accepted Answer

Operational Qualification (OQ)

Answer

Operational Qualification (OQ) verifies that equipment operates correctly within defined parameters under normal and edge conditions.

Question 4

A risk assessment using FMEA assigns a Risk Priority Number (RPN) by multiplying three factors. Which combination is correct?

Accepted Answer

Severity × Occurrence × Detectability

Answer

FMEA RPN = Severity × Occurrence × Detectability, allowing teams to prioritize failure modes for corrective action.

Question 5

Under 21 CFR Part 11, which of the following is NOT a requirement for electronic signatures?

Accepted Answer

The signature must be witnessed by a supervisor

Answer

21 CFR Part 11 does not require a supervisor witness for electronic signatures; it requires linkage, identity, date/time, and meaning.

SQA - Society of Quality Assurance Practice Test