CHA Computer Systems & Software Updates 2

Question 1

Under 21 CFR Part 11, which feature is REQUIRED to ensure electronic records used in HACCP monitoring are trustworthy?

Accepted Answer

Audit trails that record who changed data and when

Answer

21 CFR Part 11 mandates secure, computer-generated audit trails that capture date, time, and identity of any record creator or modifier.

Question 2

What is the primary purpose of computer system validation (CSV) in a HACCP-controlled food facility?

Accepted Answer

To demonstrate that software consistently performs its intended function within defined limits

Answer

CSV provides documented evidence that a computer system reliably and reproducibly performs its intended food safety functions.

Question 3

A food manufacturer replaces its temperature logging software with a new version. Which step must occur BEFORE going live in production?

Accepted Answer

Complete installation qualification and operational qualification testing

Answer

IQ and OQ testing confirm the software is installed correctly and operates as specified before it is used for official CCP monitoring.

Question 4

In the context of HACCP electronic monitoring, what does 'data integrity' specifically require?

Accepted Answer

Records must be accurate, complete, consistent, and unaltered after creation

Answer

Data integrity means HACCP records are attributable, legible, contemporaneous, original, and accurate (ALCOA principles) throughout their lifecycle.

Question 5

Which type of software change is MOST likely to require a full revalidation of a HACCP monitoring system?

Accepted Answer

Changing the algorithm that calculates CCP limit deviations

Answer

Any change that affects how the system calculates or determines CCP compliance constitutes a critical functional change requiring full revalidation.

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