CAPA Test Questions and Complete
Solutions Graded A+
Who is responsible for initiating and completing the NOE? - Answer: Initiator and Action Owner
Who is responsible for initiating and assigning Regulatory Authority Notification Assessment (RANA) -
Answer: Initiator and Action Owner
Who accepts and completes assigned Investigation Actions and MRB Follow Up Actions? - Answer:
Initiator and Action Owner
Who accepts and completes assigned CAPA Action Items - Answer: Initiator and Action Owner
What does NOE stand for - Answer: Notice of Events
What does RANA stand for? - Answer: Regulatory Authority Notification Assessment
Who oversees the completion of Action Items for a CAPA Plan - Answer: Initiator and Action Owner
Who implements CAPA Plans and completes Effectiveness Check actions? - Answer: Initiator and Action
Owner
Who completes Laboratory Investigation Checklist for OOS or Aberrant/OOT result
investigations - Answer: Initiator and Action Owner
What is the goal of event initiation for a CAPA? - Answer: Ensure the Notice of Event (NOE) is clearly
documented and is in compliance
with applicable SOPs
Solutions Graded A+
Who is responsible for initiating and completing the NOE? - Answer: Initiator and Action Owner
Who is responsible for initiating and assigning Regulatory Authority Notification Assessment (RANA) -
Answer: Initiator and Action Owner
Who accepts and completes assigned Investigation Actions and MRB Follow Up Actions? - Answer:
Initiator and Action Owner
Who accepts and completes assigned CAPA Action Items - Answer: Initiator and Action Owner
What does NOE stand for - Answer: Notice of Events
What does RANA stand for? - Answer: Regulatory Authority Notification Assessment
Who oversees the completion of Action Items for a CAPA Plan - Answer: Initiator and Action Owner
Who implements CAPA Plans and completes Effectiveness Check actions? - Answer: Initiator and Action
Owner
Who completes Laboratory Investigation Checklist for OOS or Aberrant/OOT result
investigations - Answer: Initiator and Action Owner
What is the goal of event initiation for a CAPA? - Answer: Ensure the Notice of Event (NOE) is clearly
documented and is in compliance
with applicable SOPs
