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 820, the Device History Record (DHR) must contain or reference all of the following EXCEPT:
Answer: Personnel performance review scores
The DHR documents the production history of a specific device lot, not employee HR data; personnel performance reviews are not a DHR requirement.
A company discovers that an SOP governing a critical process was not reviewed on its scheduled biennial review date. The FIRST corrective action should be:
Answer: Conduct the overdue review and document a deviation explaining the missed review
The first step is to perform the overdue review and formally document the deviation from the document control schedule to maintain a complete quality record.
In pharmaceutical GMP, 'secondary data' differs from 'raw data' in that it:
Answer: Is derived or transformed from raw data through calculation or data processing
Secondary data is produced by processing or analyzing raw data; both types are subject to data integrity requirements, but raw data represents the original observation.
Which document type establishes the approved specifications for materials, components, and finished products in a pharmaceutical Quality Management System?
Answer: Specification document (or product quality standard)
Specification documents define the approved criteria (identity, purity, potency, appearance) that materials and products must meet before acceptance.
A regulatory agency inspector asks to review all documents related to a specific complaint. This activity is known as:
Answer: Records traceability audit or document traceability review
A records traceability review traces all associated documentation—complaint, investigation, CAPA, and lot history—connected to a specific event.
The regulatory concept of 'data governance' in a pharmaceutical company most directly addresses:
Answer: Policies ensuring data is generated, stored, and managed with integrity throughout its lifecycle
Data governance defines the organizational policies, accountabilities, and controls that ensure data integrity from creation through archival and deletion.
When transferring regulatory records to a new electronic document management system (EDMS), which step is most critical from a regulatory perspective?
Answer: Validating that records migrated accurately and completely, with no data loss or corruption
Validated migration confirms that the integrity, completeness, and accessibility of all records are maintained after transfer to a new system.