Documentation & Record Management Flashcards
7 cards from real CBA 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
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?
Answer: 21 CFR 820.198, which requires complaint records to be retained for the life of the device or 2 years from release
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.
A printed SOP is found in the production area but is not stamped 'Controlled Copy.' What is the MOST appropriate auditor action?
Answer: Flag it as a document control nonconformance and verify it matches the current approved revision
Uncontrolled document copies in work areas pose a risk of personnel using outdated information; the auditor should document the finding and verify the content against the master.
Which of the following scenarios represents a 'data integrity' violation under FDA expectations?
Answer: Backdating a logbook entry to reflect when an activity actually occurred without disclosure
Backdating entries without disclosure constitutes falsification of records and a critical data integrity violation regardless of whether the underlying activity occurred.
How should a biomedical company handle a situation where a regulatory agency requests records that have been destroyed per the retention schedule?
Answer: Inform the agency that the records were destroyed in compliance with the documented retention policy
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.
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?
Answer: Each electronic signature must be unique to one individual and not reused or reassigned
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.
During a supplier audit, you find that the supplier does not have a formal procedure for controlling customer-supplied documents such as specifications and drawings. This finding MOST directly impacts:
Answer: Assurance that the supplier manufactures to the latest approved design specifications
Without control of customer-supplied specifications, the supplier may inadvertently use an outdated drawing, producing parts that do not meet current design requirements.
Which of the following BEST supports the concept of 'traceability' in biomedical device documentation?
Answer: Linking raw material lot numbers, production records, and test results to a specific finished device
Traceability requires the ability to connect every component, process, and test result to a specific finished device unit or lot, enabling effective investigations and recalls.