The U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help regulators be more efficient with their resources, but they also will require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on its quality systems. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Now is the time to revisit cost-vs.-benefit analyses for continuous monitoring systems (e.g., wired or wireless networks, and standalone monitoring instruments) that facilitate proof of regulatory compliance.

Moreover, the ever-increasing costs for active pharmaceutical ingredients (APIs) and the research and development efforts to create them mean that the economic effect of monitoring-system failure is greater than ever before. All monitoring methods, whether wired, wireless, or standalone, should be scrutinized for systemic weaknesses that allow human error to compromise product quality, system-failure probabilities, and overall costs of ownership.

Quality, facility, and information technology (IT) managers employ different methods for maintaining the quality of products and information. This two-part article evaluates six different temperature- and humidity-monitoring methods, and presents the risks and costs of ownership for each.

Paper-based chart recorders, powered either by AC power or batteries, are the oldest technology. 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. Although this technology continues to evolve and remains the mainstay of most pharmaceutical operations, wireless is fast becoming 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.

Pharmagraph software has been written from the ground up to comply with the tough demands of 21 CFR part 11 through the use of tight security, proprietary binary logging and provision of an audit trail. The software system is secured via unique user names and passwords, with automatic log out when the system is left idle. A secure binary format is used for data log files making it virtually impossible to alter records. An audit trail logger automatically tracks changes to the system configuration, recording what has been changed, by whom, when and for what reason. The audit trail logger also records operator log in and log out activity, including failed log in attempts.