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
Under 21 CFR Part 11, which feature is REQUIRED to ensure electronic records used in HACCP monitoring are trustworthy?
Answer: Audit trails that record who changed data and when
21 CFR Part 11 mandates secure, computer-generated audit trails that capture date, time, and identity of any record creator or modifier.
What is the primary purpose of computer system validation (CSV) in a HACCP-controlled food facility?
Answer: To demonstrate that software consistently performs its intended function within defined limits
CSV provides documented evidence that a computer system reliably and reproducibly performs its intended food safety functions.
A food manufacturer replaces its temperature logging software with a new version. Which step must occur BEFORE going live in production?
Answer: Complete installation qualification and operational qualification testing
IQ and OQ testing confirm the software is installed correctly and operates as specified before it is used for official CCP monitoring.
In the context of HACCP electronic monitoring, what does 'data integrity' specifically require?
Answer: Records must be accurate, complete, consistent, and unaltered after creation
Data integrity means HACCP records are attributable, legible, contemporaneous, original, and accurate (ALCOA principles) throughout their lifecycle.
Which type of software change is MOST likely to require a full revalidation of a HACCP monitoring system?
Answer: Changing the algorithm that calculates CCP limit deviations
Any change that affects how the system calculates or determines CCP compliance constitutes a critical functional change requiring full revalidation.
A HACCP auditor discovers that the facility's electronic HACCP records can be edited without generating an audit trail entry. What is the correct audit finding classification?
Answer: Major nonconformance — system does not meet 21 CFR Part 11 requirements
The inability to capture data changes in an audit trail is a major nonconformance under 21 CFR Part 11 and undermines HACCP record reliability.
What does 'electronic signature' mean under 21 CFR Part 11 as applied to HACCP records?
Answer: A computer data compilation legally equivalent to a handwritten signature
21 CFR Part 11 defines an electronic signature as a computer-compiled set of symbols executed with legal intent, equivalent to a handwritten signature.