Data Recording and 21 CFR Part 11
| Eurotherm Chessell offers a new range of products with 21 CFR Part 11 capability. Termed the Series 5000, three hardware products and two software products provide the user with the 21 CFR Part 11 features required. High security data recording is provided in internal memory plus on board data media such as PCMCIA card or floppy disk plus full Ethernet network capability for archival of data automatically using Review software. A further software package called Bridge enables remote access to the data via the Ethernet network. Data can be retrieved via local area network (LAN), wide area network (WAN) or via the Internet. Security procedures are available to prevent unauthorized access. |
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| The 5100V ( 5.5 inch touch screen ) and 5180V ( 12.1 inch touch screen ) with auditor features offer data recording with the addition of the capabilities required to be compliant with the rule. Capable of stand alone operation or integration into a factory wide Ethernet network using Modbus TCP/IP protocol, these products are aimed specifically at the pharmaceutical / healthcare market. |
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| A further product, termed the 5000B, offers data collection, on board storage plus networking of data via Ethernet. In the case of the 5000B visualization of the data is achieved via the network on the Bridge software. This product is finding a wide range of uses. This product is commonly used to monitor not just process conditions but also environmental conditions, which are of significant importance to the pharmaceutical industry. Advanced features in the Series 5000 now include Time Synchronization and the MKT equation. Time synchronization ensures that all nodes on the network share a common time reference and the inclusion of the MKT (Mean Kinetic Temperature) provides a measure to the storage conditions of the finished products as noted in the FDA Draft proposal Documents |
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