Computer Systems & Software Updates Flashcards
7 cards from real CHA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Computer Systems & Software Updates flashcards as text
A facility's HACCP software update includes a patch that modifies how the system stores CCP temperature readings. What document must be updated FIRST?
Answer: The software change control record
A formal change control record must be initiated before implementing any software modification that affects CCP data storage or processing.
Which qualification protocol verifies that a newly installed HACCP monitoring software performs correctly under actual production conditions?
Answer: Performance Qualification (PQ)
Performance Qualification (PQ) tests the system under real production conditions to confirm it meets HACCP monitoring requirements in actual use.
When a HACCP auditor reviews a computer system change log, what is the MOST critical element to verify?
Answer: That each change was authorized, tested, and approved before implementation
Effective change control requires documented authorization, testing results, and approval signatures before any change goes live in a regulated HACCP environment.
A facility uses automated software to flag CCP deviations and trigger corrective action notifications. During an audit, the system fails to flag an actual deviation. This represents a failure of:
Answer: Software performance qualification requirements
Failure to detect and flag a real CCP deviation is a performance qualification failure, indicating the system does not meet its validated functional requirements.
In a HACCP computer system, what is the purpose of maintaining a 'system specification document'?
Answer: To define the intended functions, inputs, outputs, and performance requirements of the system
The system specification document is the baseline reference that defines what the software must do, enabling validation activities to verify those requirements are met.
A software update is rolled back after it causes erroneous CCP alerts. What HACCP documentation action is required?
Answer: A deviation report and corrective action record documenting the impact on HACCP monitoring
Any software failure that affected HACCP monitoring must be documented as a deviation with a formal corrective action record addressing root cause and impact assessment.
Which federal regulation specifically governs electronic records and electronic signatures used in FDA-regulated food facility HACCP systems?
Answer: 21 CFR Part 11
21 CFR Part 11 is the FDA regulation that establishes criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures.