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 ISO 13485:2016, how long must records of implantable medical devices be retained?
Answer: At least 10 years, or the lifetime of the device as defined by the organization, whichever is longer
ISO 13485:2016 Clause 4.2.5 specifies a minimum retention period of 10 years or the device's defined lifetime, whichever is greater, for implantable devices.
A 'ghost authorship' situation in regulatory documentation—where a document is attributed to someone who did not meaningfully contribute—primarily violates:
Answer: Data integrity principles, specifically the 'attributable' requirement of ALCOA
ALCOA's 'Attributable' principle requires that the actual person performing an activity or generating data be identified in the record.
In a regulated environment, a 'predicate rule' in the context of 21 CFR Part 11 refers to:
Answer: The underlying FDA regulation (e.g., 21 CFR Parts 211, 820) that requires the record to be kept
Predicate rules are the specific FDA regulations that require certain records to be maintained; Part 11 governs the electronic format of those records.
Which scenario would be considered a 'data integrity failure' during an FDA inspection?
Answer: Analysts sharing login credentials to access a chromatography data system
Shared login credentials destroy individual attributability of electronic records, a core 21 CFR Part 11 and ALCOA requirement.
A Document Numbering System in a Quality Management System primarily ensures:
Answer: Unique identification of each document to prevent confusion between similar documents
Unique document numbers prevent retrieval errors and ensure personnel reference the correct procedure, form, or specification.
Under the FDA's Quality System Regulation, which type of record documents the manufacturing instructions and specifications used to produce a specific product?
Answer: Device Master Record (DMR)
The DMR contains the approved instructions, specifications, and procedures for manufacturing a device, while the DHR documents the actual production of a specific lot.
When an FDA investigator requests a record and the company states the document was 'not retained,' what is the likely regulatory consequence?
Answer: A Form 483 observation or Warning Letter citing failure to maintain required records
Failure to maintain required records is a GMP violation documented in FDA 483 observations and can escalate to Warning Letters or consent decrees.