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Defining Data Demands

Mon, 02/23/2009 - 9:57am

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The difference between On-Demand Data and Data Demanding Your Attention


Successful management of pharmaceutical quality has always required attention to accurate environmental monitoring and timely analysis of temperature trends, or often humidity trends as well. If you think that the quality management teams that devote many hours to this task are setting the bar for best practices, you may be mistaken. In many cases this would reflect instead a reliance on temperature and humidity monitoring instruments that require more labor to operate, not a higher standard of diligence.

While many pharmaceutical quality managers tend to prefer the models of chart recorders and data loggers that they have long been accustomed to, there are many reasons to consider the labor costs associated with use of these particular monitoring instruments. Savings in staff hours can be considerable if one trades up to more recent instrument models. For example, a few years ago Ethernet enabled data loggers that allow managers to keep an eye on all the loggers in their facility from one desktop were introduced. These not only eliminate the need to constantly patrol facilities looking at in situ loggers but also allow managers to simply log into the Internet to monitor data loggers from whatever location they are in.

When it comes to time savings, however, wireless data loggers are far and above the most efficient monitoring instruments now available. The first source of time-savings by going wireless, but certainly not the only time-savings, is that wireless data loggers totally eliminate the need to download data. This savings is not trivial, as Figures 1 and 2 help to show. Most pharmaceutical processing plants are relatively large, and require constant monitoring of inventory and finished products in addition to the processing areas per se. When you have multiple loggers throughout a facility, and staff taking time to gather data from loggers—even if data is transferred via FLASH memory cards, this time certainly does add up, as does the budget to support this staff time.

The elimination of time needed for downloading data is actually only the beginning of time savings one gets with wireless technology, at least with the better wireless instruments that are now available. The wireless data loggers available for the pharmaceutical industry are not only 21 CFR Part 11 compliant, but also they automatically store and archive data in a tamper-proof database. The better wireless loggers have features that allow you instantaneous access to data—all data, current and historical. To zoom in on data from a particular date takes nothing more than a click of the mouse on a point on a graph shown on a PC monitor. This is known as "on-demand data", and it is a feature one is well advised to make sure is included in any wireless data logger you are considering because it saves considerable time that would otherwise be spent trolling through data archives.

There are also time-savings in data analysis tasks when you use wireless data loggers. For example, the better wireless data loggers will also allow you to view any multiples of data loggers in your facility on one graph. You can then zoom in and out and zoom by date range to create whatever graphs you desire for analysis at any time. Again, it's all done automatically with just a few moves of a computer mouse. And, when one has access to such on-demand data, it is also just a few keystrokes to export the graphs and tables you create to other analytical software such as Excel.

Then there is the category of "data that demands your attention". Most pharmaceutical quality managers have long understood that extra steps need to be taken to ensure that out-of-range conditions are noticed in time for remedial actions to be taken before it is too late. Audible alarms and visual alarms on data loggers distributed throughout facilities have long been required in most pharmaceutical applications. Obviously when these alarms come directly to a manager's desktop they are even better. The best-in-class data loggers will take this principle of ensuring that the data can demand your attention one step further by having automatic triggering of high priority email messages and phone text messages to a pre-set distribution list of quality team members in addition to audible alarms at a manager's desktop. And better still are the best-in-class wireless data loggers that not only have all these "demand your attention" features but also display ALL data – current and past—to any and all computers on a computer network as desired. This means that a "failsafe" standard for environmental monitoring is newly within reach when you switch to modern wireless monitoring technology.

Granted, for those pharmaceutical quality managers who want to stick to their tried and true data logger and chart recorder models there may not be enough incentive to switch. Dickson manufactures the widest assortment of data loggers and chart recorders because of our desire to accommodate such varying preferences for one or another model.

However, we are also aware that there is still a good deal of misinformation among pharmaceutical quality managers as to what wireless instruments can and cannot do, that is causing some to stick to older technologies. Some mistakenly think, for example, that there is no way to capture data if wireless connections are lost and further that there is no way to know with assurance that wireless connections are workable. Actually, the better wireless data loggers will not only create 21 CFR Part 11 compliant databases automatically but will also keep more than a week's worth of data as backup in the loggers themselves. Also, for quite some time now, the better wireless instruments have provided 24/7 feedback on wireless network status and verification that signals are being received. If the wireless feedback loop is broken, there are alarm systems on desktops alerting managers to the need for remedial action. Before such failsafe features existed, there was reason to eschew wireless instruments, but that has not been the case for a few years now. Better yet, reputable manufacturers of wireless data loggers will always allow you to test these instruments in your plant without cost or obligation.

About the author: Chris Sorensen is VP of Dickson Company (www.DicksonData.com). Inquiries can be directed to dicksoncsr@dicksondata.com, 630.543.3747, FAX 630.543.0498, 930 S Westwood, Addison IL, 60101.

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