FDA Compliance to PMO criteria for the evaluation of electronic data loggers

Electronic data loggers are a suitable replacement for paper chart recorders in Pasteurized Milk Ordinance

“Electronically collecting data, storing data and reporting information with computers can be a beneficial replacement for circular chart recorders and/or hand-written records.” – FDA Pasteurized Milk Ordinance 2013, Appendix H, Section V, page 263.

Data logging in dairy pasteurization

Historically, process data logging in dairy pasteurization applications has been accomplished through the use of paper chart recorders, typically the circular paper models. There has been little advancement in paper chart recording technology and little emphasis on the transition from paper chart logging to electronic data collection, due to the cost of hardware and the perceived complications of software installation. However, the cost of operation and upkeep of paper chart recorders is increasing every year due to the need for on-site record storage and new requirements for on-demand access to the data. Additionally, the cost of replacement mechanical parts, pens, and charts is growing. During this time, modern electronic data recorders have become more economic, and the network infrastructure required for data storage has become significantly less demanding, depending on the scale of the system. This leads dairy processors to a decision between staying with an existing, ageing paper system or upgrading to a modern, user-friendly electronic data collection system.

According to the PMO, electronic data recording systems may be beneficial replacements for circular paper chart recorders; particularly considering the cost savings and reliability when dealing with electronic data over traditional paper data. However, in order for the electronic data collection systems to be considered, vendors or manufacturers must describe how the recording products comply with the twelve criteria dictated by the PMO.

The purpose of this white paper is to describe how, where appropriate, the Eurotherm electronic data recording strategy complies with the requirements of the PMO found in Appendix H, Section V.

Advantages of electronic data recording in PMO

Never lose data

• In-situ UPS
• Data recorded in internal memory
• Store-and-forward self-healing data transfer strategy

Sample rates and data backups

• Data sampled once every 125ms
• Up to 125ms recording rate easily meets 5s requirement
• Backup by USB, FTP or Eurotherm Review archiving software

Capture unusual occurrences

• 125ms sample rate to capture events
• Operator messages
• Scheduled backups

Digital signatures and initials

• Review, annotate and sign digitally in Review software
• Audit trail option for password, access and permission management
• USB ports for barcode /biometric data entry

Record Anomalies

• Alarms logged in memory
• Time and date stamped messages
• Permanently recorded with the data