Most every day FDA agents make surprise inspections to ensure production lines meet their regulations. That takes a lot of travel time and manpower. Recently, the agency noted that remote monitoring might be as useful. “Apparently, the FDA would like to check inputs, outputs, temperatures, pressures, and more, online,” says Kim Anderson, business development manager at Turck, Plymouth, Minn. (turck.com). “The EPA also supports the concept.”

The idea of remote monitoring has been around a while but was expensive to implement. “For instance, just validating a control system can cost seven to ten times the cost of the controls. Consultants hired to inspect control architectures usually do so in minute detail, making sure it follows GMP, and that it makes a repeatable product. That takes three to six months. Add remote monitoring and the costs jump. A consumer-product manufacturer commented that to allow an outside agency to look at its processes online required adding $10,000 modules and hierarchical control strategies,” says Anderson.

And there is another problem. “Adding remote monitoring that relies on older technology could put the control system at risk. There is a small possibility controls could be tampered with,” he says.

But now there is Ethernet connectivity. Some Turck products, for example, have Web servers built in. These simplify sending information such as temperature, pressure, and flow readings to various agencies because it's “read only”, which prevents altering a validated control system. Ethernet connections to control systems could be accessed by those external to the operation. “And monitoring systems cost about $1,100 to $1,500, potentially saving thousands over a hierarchical strategy,” says Anderson.