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Device Management Solution Brings 21 CFR 11 to Handhelds

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Meriam Process Technologies, a Cleveland-based supplier of calibration- and data-management systems, has released a new device-management solution designed to ensure the validity and integrity of instrument data over the life cycle of a plant. The solution combines completely automated configuration, calibration, test and documentation procedures with electronic signatures, and extends the signatures to the level of the handheld instrumentation.

The new software is designed to ensure that calibration and configuration procedures and results are valid and secure. Its new functionality eliminates any potential for unauthorized tampering with devices or data , a common flaw in existing plant asset management systems.

The solution consists of Device Management System (DMS) software release 2.0 as well as two field-upgradeable hand held devices, the MFT 4000 series documenting process calibrator and MFC 4100 documenting HART communicator. Both the MFT and MFC feature electronic signature capability.

Compliance with the FDA's 21 CFR 11 regulations requires an electronic signature for any action on a field device. Solutions for configuration and calibration of field devices, in many cases, still include a manual data portion and, until now, the electronic signatures are filled in when collected data is uploaded. There is no check on whether a user actually collected data or whether he or she was authorized to do so. This weak link can permit invalid or falsified record keeping, exactly the problem that FDA is trying to prevent.

"The key advantage that we built into the new Meriam technology is enabling an electronic signature right down to the hand held device level," explains Louis Szabo, vice president. "Only authorized users can effect changes to configurations and perform calibration functions. Every step is electronically secure, including retrieving and storing configuration and calibration data. The ideal solution, unavailable until now, is secure and eliminates any unauthorized tampering with the actual devices or data."

The system is managed almost completely by the new DMS software package, which initiates most of the 21 CFR 11 processes and handles users, privileges, device assignments, database integrity, electronic records and audit trail. This software is also the watchdog for data tampering.

The system carefully orchestrates balances between command and record, and manages them electronically. First, an administrator assigns work schedules to authorized users. Next, these work schedules are downloaded to the appropriated MFT or MFC handheld tools. Finally, the user is asked to enter a username and password, which is recorded along with the work performed. The system locks out anyone not authorized to implement scheduled work, creating a secure environment.

"DMS is a lifecycle tool," explains Szabo. "It tracks device history from an electronic birth certificate, through electronic bills of health through device retirement with an electronic death certificate. With our DMS' new 21 CFR 11 capability, the user has a detailed record of the maintenance action performed on virtually every field device in their plant."

Along with automated data communications with smart instrument calibrators, the PC-based DMS software program includes many other functions, including multi-level plant structure support; tracking of loops, positioners and devices; and scheduling of maintenance work, including calibration and inspections. The software is built on Microsoft .Net technology, combining the power and flexibility of the client-based model with the ease of deployment and stability of the browser-based model.

DMS is provided with an SQL server database, and information can also be transferred to and from other databases such as Oracle and dBase. DMS also supports XML and other interconnectivity tools to allow flexible integration with other information systems, including MRO and CMMS interfaces.

"The new Meriam device management solution significantly increases system security," concludes Szabo. "Plus, the system's potential to minimize documentation paperwork and reduce maintenance downtime by up to 50% necessarily increase plant productivity and profitability." For more information, call 216-281-1100 or visit http://www.meriam.com.

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