CBA Documentation & Record Management 3 — Questions and Answers
Question 1: What is the PRIMARY purpose of a Master Document List (MDL) in a quality management system?
- To train new employees on document usage
- To provide a current inventory of all controlled documents and their revision status (Correct answer)
- To serve as an index for regulatory submissions
- To track employee acknowledgment of document changes
Correct 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.
Question 2: 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?
- A supervisor co-signature on the correction
- The reason for the change (Correct answer)
- A new batch record to replace the corrected one
- An electronic backup of the original entry
Correct 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.
Question 3: Under ISO 13485:2016, which of the following is considered a 'quality record' rather than a 'quality document'?
- Work instruction for equipment calibration
- Completed calibration log for a specific instrument (Correct answer)
- Approved SOP for nonconforming product control
- Quality manual describing the QMS scope
Correct 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.
Question 4: 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?
- Require the revision level to be incorporated into the document number
- Ensure revision levels are clearly displayed on the document face and in the MDL (Correct answer)
- Switch to a purely sequential numbering system
- Require all documents to be stored in a validated EDMS
Correct 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.
Question 5: Which scenario BEST demonstrates the concept of 'data integrity' in documentation?
- A technician re-records data from memory hours after completing a test
- Data is recorded directly into the batch record at the time of the activity (Correct answer)
- A supervisor reviews and countersigns all entries within 24 hours
- Electronic records are backed up nightly to a secure server
Correct 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.
Question 6: 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?
- Employee safety requirements
- Record legibility and protection requirements (Correct answer)
- Calibration traceability requirements
- Device labeling requirements
Correct 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.
Question 7: 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?
- Training all department heads on the new system
- Validating the EDMS to confirm it meets intended use requirements (Correct answer)
- Migrating all legacy documents to the new system
- Defining user access roles and permissions
Correct 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.
CBA Documentation & Record Management 3
What is the PRIMARY purpose of a Master Document List (MDL) in a quality management system?