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
What is the PRIMARY purpose of a Master Document List (MDL) in a quality management system?
Answer: To provide a current inventory of all controlled documents and their revision status
An MDL (or document register) provides a single source of truth for all controlled documents, their current revision levels, and status within the QMS.
A correction is made to a paper batch record by drawing a single line through the error, initialing, and dating the correction. What additional element is REQUIRED by ALCOA principles?
Answer: The reason for the change
Good documentation practice requires that corrections include the reason for the change in addition to the single strikethrough, initials, and date.
Under ISO 13485:2016, which of the following is considered a 'quality record' rather than a 'quality document'?
Answer: Completed calibration log for a specific instrument
Quality records are completed, filled-in forms (objective evidence of activities performed), while quality documents are instructions or policies used to guide activities.
A biomedical company uses a document numbering system that encodes department and document type. An auditor cannot determine the current revision from the document number alone. What is the MOST appropriate corrective action?
Answer: Ensure revision levels are clearly displayed on the document face and in the MDL
While revision levels need not be in the document number, they must be clearly and unambiguously displayed on the document itself and tracked in the master document list.
Which scenario BEST demonstrates the concept of 'data integrity' in documentation?
Answer: Data is recorded directly into the batch record at the time of the activity
Data integrity requires that data be recorded contemporaneously — at the time the activity is performed — to ensure it is accurate and original.
During an internal audit, you find that batch records are stored in an area with no temperature or humidity controls, and some are showing moisture damage. Which regulatory requirement is MOST at risk?
Answer: Record legibility and protection requirements
Regulations such as 21 CFR 820.180 require records to be stored in a manner that prevents deterioration and ensures they remain legible and retrievable.
A company is transitioning from paper to an electronic document management system (EDMS). Which step is MOST critical before the EDMS goes live for controlled documents?
Answer: Validating the EDMS to confirm it meets intended use requirements
System validation (IQ, OQ, PQ) must be completed and documented before an EDMS is used for regulated records to ensure it performs as intended.