Wednesday, 31 March 2010

21CFR part 11 complience data acquisition and display

The latest version of Yokogawa's DXAdvanced DAQSTATION range of data acquisition and display stations - the DXAdvanced R4 - features a number of new enhancements including an advanced security option that provides 21CFR Part 11 compliance, multi-batch capabilities, a ProfiBus interface and the new DAQManager data management software.

The advanced security option (/AS1) incorporates all the features required to provide secure electronic records to comply with the US Food & Drug Administration's 21CFR Part 11 standard (pdf), including controlled system access, active directory password management, electronic signatures, and an audit trail.

The DXAdvanced R4 has evolved from Yokogawa's paperless recorder technology to become a complete data-acquisition station with built-in panel, and offers integrated display, recording and communication functions. Two models are available:
the DX1000 with a 5.5-inch LCD panel and up to 12 input
channels, and
the DX2000 with a 10.4-inch LCD panel and up to 48 input channels.
The new models also feature high-capacity internal storage, with 400 Mbyte of secure non-volatile flash memory to support uninterrupted recording of more data over longer time periods.

The multi-batch function allows the user to record pre-defined channel groups to separate data files with independent start and stop control. Up to six batches can be created on the DX1000 and up to 12 on the DX2000.

DXAdvanced R4 offers custom display screens that allow the user to freely arrange field displays along with trend curves, bar graphs and other visuals. DAQStudio builder software can be used to create and edit custom display screens on a PC.

The new DAQManager software allows the user to manage measured data from the DXAdvanced DAQSTATION and Yokogawa's MVAdvanced family of paperless recorders on a PC. Data loaded onto DAQManager can be quickly and easily searched by data/time, tag name, batch name and other criteria.

The PROFIBUS interface, along with support for PROFIBUS-DP and EtherNet/IP protocols, enables the DXAdvanced DAQSTATION R4 to be integrated into end-user applications to provide a much wider range of functions than data acquisition and recording. In particular, it can be used with Yokogawa's MW100 data-acquisition system and other vendor's I/O products to provide many additional input channels. Then, using the optional maths and events
functions of the DXAdvanced DAQSTATION, the unit can be used to initiate actions or alarms based on the acquired data.

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