New Calibration Management Suite Facilitates 21 CFR Part 11 Compliance

Aug. 5, 2003

Although smart instrument calibrators are capable of automatically storing calibration data, then transferring that data via a communications port or wireless infrared data link to a host management systems, many plants still log and record calibration data in a manual fashion.

To help streamline this cumbersome process "yet comply with FDA's electronic recordkeeping requirements--Beamex has introduced the CMX software system to provide a universal platform for automated retrieval and storage of instrument calibration data. The software includes a host of special features specifically applicable to the pharmaceutical industry and to other FDA-regulated industries.

"CMX complies with 21 CFR Part 11 and excels at security, audit trails, electronic signatures and change management control," says Sami Koskinen, Beamex's software product manager. Among the features that facilitate 21 CFR 11 compliance are records change management and audit trails, password security, electronic signature support and a uniquely identified master history record for each instrument. Also included are predefined procedures, calibration intervals and error limits as defined in the GAMP 4 "Guide for Validation of Automated Systems."

The latest generation of calibration maintenance management software from Beamex of Marietta, Ga, CMX is the successor to the company's QM6 - Quality Manager and to CALDB/HISDB. These products are currently installed in over 2,000 applications worldwide and have been in use since 1986.

In addition to automated data communications with smart instrument calibrators, the PC-based CMX software program also includes many other functions such as multi-level plant structure support; tracking of loops, positions and devices; and scheduling of calibration maintenance work.

Multi-level plant structure support allows a user to categorize plant instrumentation in virtually any desired format. One common format is plants, units (major segment of a plant), processes (one or more processes in a unit), loops and tag numbers.

Tracking of loops, positions and devices is simplified because CMX tracks instruments by serial number. Scheduling of calibration maintenance is facilitated by automatic generation of calibration forms.

According to Koskinen, "Automating calibration, test and documentation procedures significantly increases productivity and assures the validity of data." One of the keys to automation of calibration activities is elimination of manual data entry.

The CMX software communicates with Beamex calibrators as well as models from Fluke, Druck and others. In addition to retrieving and storing calibration data, CMX also can download text information to instrument calibrators. Common downloads include procedures, reminders and safety-related information.

Built on Microsoft's .Net technology, CMX is designed to support the new generations of rich applications being developed for the .Net framework. "CMX's smart client application model combines the power and flexibility of the rich client model with the ease of deployment and stability of the browser-based model," says Koskinen.

CMX is provided with a SQL server database, and information can also be transferred to and from other compliant databases such as Oracle and dBase. CMX also supports XML and other interconnectivity tools to allow flexible integration with other information systems such as SAP, Maximo and DataStream.

Through .Net, CMX supports smart client and client-server technologies. Access is full-featured and users can perform data entry and data access to and from CMX via any standard Web browser. Browsers can be PCs, personal digital assistants, or WAP-enabled phones.

Thin client access allows users to access CMX through stripped-down PCs, terminals or other access platforms via .NET technology. As with browsers, thin clients can access CMX without purchasing and installing extra software on their access platforms.

Automated data retrieval from smart instrument calibrators is one of the key features of CMX, but the program also supports manual data entry. When "dumb" calibrators are used, CMX can generate custom data recording forms to standardize manual recording of calibration parameters.

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