PAPERLESS RECORDING IN GRADE 'A' PMO CONTINUOUS FLOW PASTEURIZATION APPLICATIONS

摘要

Regulations pertaining to electronic records and signatures are incorporated into Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11)~1. This paper explores the effects 21 CFR Part 11 requirements can have for data recording in a Grade "A" Pasteurized Milk Ordinance (PMO)~2 continuous flow milk pasteurization environment. To provide a baseline for discussion, the paper opens by reviewing some of the instrumentation and controls necessary in a typical HTST (High-Temperature, Short-Time) pasteurization application, including traditional paper-based recorders. Next, the discussion reviews some paperless recording methods in the PMO regulated environment, including some of the considerations and advantages in transitioning to a paperless recording solution. The discussion concludes by reviewing the advantages and benefits of a paperless recorder designed specifically for pasteurization applications and some of the challenges users may confront when changing to paperless recording solutions.