Monday, March 31, 2014

Recorders comply with FDA 21 CFR Part 11!

Yokogawa has announced release 2 of the SMARTDAC+(R) GX and GP series paperless recorders. With these new versions, which are to be released next month (April 2014), all GX series panel-mounted recorders and GP series portable recorders will comply with the FDA 21 CFR Part 11 guidelines, and accommodate an increased number of inputs. In addition, a new graphics display function is available as an option.

Development background
Recorders are used on production lines and by R&D personnel in various industries to acquire, display, and record data such as temperature, voltage, current, flow rate, and pressure. Today, Yokogawa is one of the world’s top suppliers of recorders.

A shift from paper recording systems to digital recording systems is currently underway, and these digital devices are often used on networks. There is also an increased demand for touch-panel user interfaces like those found on mobile devices and the capability to centrally handle a larger number of inputs from devices spread out over a wide area. To accommodate such needs, Yokogawa announced the release of its GX and GP series recorders in October 2012.

With the functions that are included in release 2, the GX and GP series recorders now comply with the FDA 21 CFR Part 11 guidelines that are widely followed within the pharmaceutical industry, are capable of handling an even larger number of device inputs, and are easier to use.
Enhancements

  1. Compliance with FDA 21 CFR Part 11 - In response to requests from US pharmaceutical companies, the FDA 21 CFR Part 11 guidelines were issued in 1997. These stipulate what is required for electronic records and electronic signatures to have the same validity as paper-based records and signatures. With release 2, the GX and GP series recorders now comply with the FDA guidelines on the use of electronic records and electronic signatures in production operations. It is expected that the Yokogawa recorders will also comply with similar regulations that have been established in countries other than the United States.
  2. Accommodation for up to 450 inputs - With release 2, the GX and GP series recorders can now be used with up to six expansion units, each of which can accommodate up to 60 inputs. Including direct inputs, this gives each recorder the ability to handle a combined total of up to 450 inputs. The cables connecting the expansion units and the recorders can be up to 100 metres in length, which allows the expansion units to be installed closer to sensors and thereby reduces cabling costs.
  3. Custom-designed graphics display function (optional) - A new display function is now available that allows users to supplement the recorder’s standard figure and chart templates by uploading graphics that can be created using a separate image editing program. For example, a graphic of a water tank or some other facility can be prepared that can be displayed together with temperature and pressure values on the recorder screen. With this function, a recorder can also function as a process display unit or console panel, in addition to its main data recording function.


Major markets for the GX series include production plants in industries such as iron and steel, petrochemicals, chemicals, pulp and paper, food, pharmaceuticals, water supply and wastewater treatment, and electrical equipment and electronics. For the GP series, they include R&D units in industries such as consumer electronics, automobiles, semiconductors, and new energy; universities; and research institutes

Applications include acquiring, displaying, and logging data such as temperature, voltage, current, flow rate, and pressure.

Future product development
SMARTDAC+ stands for smart data acquisition and control. In addition to the GX series and GP series paperless recorders, the introduction of other products series as well as input modules for a variety of signal sources and output modules for control applications is planned for the SMARTDAC+ system, thereby supporting a wide range of data-gathering control applications such as production process monitoring and performance evaluation. As a leading company in the recorder market, Yokogawa will continue to respond to a wide variety of needs with the release of new products for the SMARTDAC+ system.

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