Documentation & Record Management Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation & Record Management flashcards as text
Under 21 CFR Part 11, which technical control is required to ensure electronic record integrity over time?
Answer: Audit trails that record date, time, and operator identity
21 CFR Part 11 mandates audit trails that capture who made a change, what was changed, and when, to ensure electronic record integrity.
A Document Change Control procedure must include which of the following elements?
Answer: Impact assessment of the change on related documents and processes
Impact assessment ensures that changes to one document do not inadvertently invalidate or conflict with related documents or validated processes.
Which retention period applies to device master records (DMR) under 21 CFR Part 820 for a Class III medical device?
Answer: The expected life of the device or 2 years, whichever is greater
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.
In a regulatory submission, a 'controlled document' is best defined as:
Answer: A document subject to a formal approval, version control, and distribution process
Controlled documents are managed through a defined lifecycle including authoring, review, approval, distribution, revision, and retirement.
When a Standard Operating Procedure (SOP) is retired, what is the best practice for handling the document?
Answer: Archive it with its superseded status clearly marked and retain per the document retention schedule
Retired SOPs must be archived rather than destroyed to support historical investigations and regulatory inspections.
An 'as-built' configuration record in regulatory documentation primarily serves to:
Answer: Document the exact specifications of a product as actually manufactured
As-built records provide a verified snapshot of the final product configuration, supporting traceability and post-market surveillance.
Which practice is a CAPA (Corrective and Preventive Action) record required to demonstrate according to 21 CFR 820.100?
Answer: Verification or validation of corrective action to ensure it does not adversely affect the finished device
21 CFR 820.100 requires that CAPA effectiveness be verified or validated before the action is closed to confirm the root cause was eliminated.