Compliance, Risk and Cost of Ownership Comparisons for Critical Laboratory and Facility Continuous Monitoring - Wired, Wireless and Standalone Systems - Ken Appel

Worldwide, there is growing concern about how to protect public safety and increased cooperation among regulatory agencies to audit laboratories and facilities subject to GLP and GCP guidelines. As agencies focus inspection resources on risk-based areas, there is greater scrutiny to existing regulations such as the US Food and Drug Administration’s review of how the storage of electronic data, 21 CFR Part 11, is being applied in the laboratory environment and elsewhere. Recently, the FDA has considered amendments to GLP regulations to include enforcement of sites that were previously excluded from GLP inspections.

Moreover, the ever-increasing costs for R&D efforts to create medicines the clinical studies that prove them out, and the post-marketing tests to validate quality are such that the economic costs of failure in the totality of monitoring systems are greater than ever before. All monitoring methods, whether wired, wireless or standalone instrumentation, need to be evaluated for systemic weaknesses that allow human error to compromise product quality, system failure probabilities and overall costs of ownership.

This paper discusses six approaches to monitoring critical environments such as refrigerators, freezers, incubators, rooms, and other controlled storage areas for specimens and products: 1) wired systems with UPS power backups; 2) wired systems with UPS and use of PoE (Power over Ethernet); 3) wireless WiFi; 4) wireless mesh; 5) non-networked/standalone data loggers; and 6) chart recorders.

Briefly, chart recorders are the oldest technology - paper-based, powered either by AC or batteries. Standalone non-networked data loggers also use either AC or batteries, and require manual downloading of data at regular intervals. Wired networking technology has been around for decades. While this technology continues to evolve and remains the mainstay of most life science operations, wireless has fast become an interesting alternative. Each method of communicating data has its advantages and disadvantages. When it comes to regulatory-compliant applications involving public health, however, the criteria for using one method over the other should be well understood. The following two charts provide an overview of risk factors and cost-ofownership differences between the continuous monitoring modalities.