CRAP Documentation & Record Management 2

Question 1

Under 21 CFR Part 11, which technical control is required to ensure electronic record integrity over time?

Accepted Answer

Audit trails that record date, time, and operator identity

Answer

21 CFR Part 11 mandates audit trails that capture who made a change, what was changed, and when, to ensure electronic record integrity.

Question 2

A Document Change Control procedure must include which of the following elements?

Accepted Answer

Impact assessment of the change on related documents and processes

Answer

Impact assessment ensures that changes to one document do not inadvertently invalidate or conflict with related documents or validated processes.

Question 3

Which retention period applies to device master records (DMR) under 21 CFR Part 820 for a Class III medical device?

Accepted Answer

The expected life of the device or 2 years, whichever is greater

Answer

21 CFR 820.180 requires records be retained for the expected useful life of the device or a minimum of 2 years from release, whichever is longer.

Question 4

In a regulatory submission, a 'controlled document' is best defined as:

Accepted Answer

A document subject to a formal approval, version control, and distribution process

Answer

Controlled documents are managed through a defined lifecycle including authoring, review, approval, distribution, revision, and retirement.

Question 5

When a Standard Operating Procedure (SOP) is retired, what is the best practice for handling the document?

Accepted Answer

Archive it with its superseded status clearly marked and retain per the document retention schedule

Answer

Retired SOPs must be archived rather than destroyed to support historical investigations and regulatory inspections.

(CRAP) Certified Regulatory Affairs Professional Practice Test