CBA Documentation & Record Management 2 — Questions and Answers
Question 1: Under FDA 21 CFR Part 820, what is the minimum retention period for Device History Records (DHRs)?
- 2 years from date of manufacture
- The expected life of the device or 2 years from release, whichever is longer (Correct answer)
- 5 years from the date of distribution
- 7 years from the date of manufacture
Correct answer: The expected life of the device or 2 years from release, whichever is longer
21 CFR 820.184 requires DHRs to be retained for the expected useful life of the device or 2 years from release date, whichever is longer.
Question 2: Which document controls activity must be completed BEFORE a revised procedure is implemented?
- Post-implementation review
- Approval by designated authority (Correct answer)
- Distribution to all personnel
- Employee training acknowledgment
Correct answer: Approval by designated authority
Documents must be reviewed and approved by designated authorities before implementation to ensure proper authorization under ISO 13485 and FDA QSR.
Question 3: A batch record is missing a technician's initials on a critical step. Under ALCOA principles, this finding represents a failure of which attribute?
- Accurate
- Legible
- Attributable (Correct answer)
- Original
Correct answer: Attributable
ALCOA's 'Attributable' principle requires that each recorded entry can be traced to the individual who performed and documented it.
Question 4: When an obsolete document is retrieved from circulation, what is the BEST practice for its disposition?
- Shred it immediately to prevent accidental use
- Mark it as obsolete and retain per the document retention schedule (Correct answer)
- Return it to the document control department without marking
- Archive it in its original form without any notation
Correct answer: Mark it as obsolete and retain per the document retention schedule
Obsolete documents should be marked clearly to prevent unintended use and retained according to the organization's record retention schedule for traceability.
Question 5: An auditor finds that a quality manual references a procedure that no longer exists. This is BEST classified as which type of finding?
- Observation
- Minor nonconformance (Correct answer)
- Major nonconformance
- Critical nonconformance
Correct answer: Minor nonconformance
A broken cross-reference between controlled documents is a gap in document control that typically constitutes a minor nonconformance requiring corrective action.
Question 6: Which of the following is a key requirement of 21 CFR Part 11 for electronic records in the biomedical industry?
- All electronic records must be printed and signed manually
- Electronic signatures must be linked to their respective records (Correct answer)
- Electronic records must be stored only on validated cloud systems
- Audit trails are optional if access controls are in place
Correct answer: Electronic signatures must be linked to their respective records
21 CFR Part 11 requires that electronic signatures be linked to their electronic records so any attempt to alter the record is detectable.
Question 7: During an audit, you observe that a SOP was last reviewed 4 years ago, but the company policy requires review every 2 years. This finding demonstrates a failure in which process?
- Change control
- Periodic document review (Correct answer)
- Document distribution
- Employee training
Correct answer: Periodic document review
Failure to conduct reviews on the scheduled frequency is a nonconformance in the periodic document review process, which ensures documents remain current and accurate.
CBA Documentation & Record Management 2
Under FDA 21 CFR Part 820, what is the minimum retention period for Device History Records (DHRs)?