CBA Documentation & Record Management 5

Question 1

In a biomedical audit, you discover that complaint records are being deleted after 18 months to save storage space. Which regulatory requirement does this MOST directly violate?

Accepted Answer

21 CFR 820.198, which requires complaint records to be retained for the life of the device or 2 years from release

Answer

21 CFR 820.198(g) mandates that complaint records be maintained for the expected useful life of the device or 2 years from the date of release, whichever is longer.

Question 2

A printed SOP is found in the production area but is not stamped 'Controlled Copy.' What is the MOST appropriate auditor action?

Accepted Answer

Flag it as a document control nonconformance and verify it matches the current approved revision

Answer

Uncontrolled document copies in work areas pose a risk of personnel using outdated information; the auditor should document the finding and verify the content against the master.

Question 3

Which of the following scenarios represents a 'data integrity' violation under FDA expectations?

Accepted Answer

Backdating a logbook entry to reflect when an activity actually occurred without disclosure

Answer

Backdating entries without disclosure constitutes falsification of records and a critical data integrity violation regardless of whether the underlying activity occurred.

Question 4

How should a biomedical company handle a situation where a regulatory agency requests records that have been destroyed per the retention schedule?

Accepted Answer

Inform the agency that the records were destroyed in compliance with the documented retention policy

Answer

If records were destroyed lawfully per an established and documented retention schedule, the company should inform the agency of this fact; recreating records would constitute falsification.

Question 5

An auditor is assessing a company's use of an electronic signature system. Which of the following is a key requirement under 21 CFR Part 11 for electronic signatures?

Accepted Answer

Each electronic signature must be unique to one individual and not reused or reassigned

Answer

21 CFR Part 11 requires that each electronic signature be unique to one individual and that organizations ensure no two individuals share the same electronic identity.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA Documentation & Record Management 5