Computer Systems & Software Updates Flashcards
7 cards from real CHA practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 7 Computer Systems & Software Updates flashcards as text
Under FSMA's Preventive Controls for Human Food rule, electronic records of preventive control monitoring must be retained for a minimum of:
Answer: 2 years
FSMA's Preventive Controls rule (21 CFR Part 117) generally requires that records of preventive control monitoring be retained for at least 2 years.
A HACCP auditor is evaluating whether a facility's networked CCP sensors are adequately protected from cybersecurity threats. Which control is MOST directly relevant to food safety data integrity?
Answer: Segmenting the food safety monitoring network from general business IT networks
Network segmentation isolates CCP monitoring systems from broader business networks, reducing the risk of cyberattacks corrupting or disrupting food safety data.
A software vendor releases a critical security patch for the HACCP monitoring application. What must the facility do BEFORE applying the patch in a regulated environment?
Answer: Assess the patch impact, test in a non-production environment, and follow the change control process
Even critical security patches must go through impact assessment, non-production testing, and change control documentation before being applied to validated HACCP systems.
Which term describes the documented evidence that a computer system was designed to meet HACCP and regulatory requirements before it was built?
Answer: Design Qualification (DQ)
Design Qualification (DQ) documents that the system's design specifications meet the user's requirements and applicable regulatory standards before construction or purchase.
A facility uses a SCADA system to control and monitor a pasteurization CCP. During an audit, the SCADA software version in use is found to be two major versions behind the validated version. What is the auditor's primary concern?
Answer: The system may be operating outside its validated state, making CCP data unreliable
Operating outside the validated software version puts the system outside its qualified state, potentially invalidating the reliability of CCP monitoring data.
When integrating a third-party laboratory information management system (LIMS) with a HACCP monitoring platform, what is the MOST critical validation concern?
Answer: Verifying that data transferred between systems is accurate, complete, and maintains its original integrity
System integration validation must confirm that data passing between platforms is not altered, truncated, or corrupted, preserving the integrity of HACCP and laboratory records.
A HACCP auditor identifies that the facility has no documented procedure for handling electronic records when the monitoring system is upgraded to a new major version. What risk does this create?
Answer: Historical CCP records may become inaccessible or unreadable after the upgrade, compromising regulatory compliance
Without a documented records migration or archival procedure, a major upgrade can render historical HACCP records inaccessible, violating retention and review requirements.