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April 15, 2011 (Vol. 31, No. 8)

Minimizing Weight Measurement Uncertainty

Software Helps Labs Comply with ISO, GxP, and USP Regulatory Requirements

  • LabX-Avoiding Risk

    The dictionary defines calibration as: “to determine by measurement or comparison with a standard; the correct value for each balance reading on a device.” Risk assessment is an integral aspect of each day for lab managers and technicians. But, have you considered the importance of, and the risks associated with the calibration of your balance and the accuracy that is provided?

    Can your calibration provider back you up in times of trouble, and supply documented evidence that the equipment was functioning within specification? Can their calibration procedures withstand independent scrutiny and be shown to be traceable to National Standards for accuracy of measurement, thus reducing the risk of inaccurate weighing events? These are important documents that provide tremendous support that lab and weighing activities are professionally and expertly conducted.

    The built-in test and adjustment scheduler for LabX ensures that balance calibrations are carried out as planned according to your quality management standards. Whether it’s using the internal or external weight verifications, or even performing repeatability tests, lab managers have the option to configure the calibration setting according to their requirements.

    For example, if the user accidentally forgets to execute the test, LabX can block the weighing task from running until the test is performed. LabX can also block the weighing task if the test is performed and did not pass per your established standards. This ensures that all weighing jobs will and can only be executed on a well-calibrated and tested weighing instrument, avoiding weighing risk and providing strict compliance to quality-management objectives.

    In order to support required regulation and accreditation standards, it is fundamental that LabX offers full traceability of all data and information generated within the system. This includes electronic signature acceptance and complete system security. Components of this include support for password policy, user rights management and role definition, and control of access to specific functionality. By utilizing built-in LabX features, the user can easily conform to these tough standards.

  • Audit Friendly

    Click Image To Enlarge +
    Figure 2. Mettler Toledo balance touch screen

    LabX 2010 Balance Excellence provides users step-by-step instructions on weighing tasks directly on a Mettler Toledo balance touch screen (Figure 2). All individual process steps are incorporated to provide complete workflow SOP compliance, including weight checks before the process begins. All calculations are automatically performed and all data is saved in a central database. Transcription errors are eliminated, and full traceability is guaranteed.

    Weighing methods are created and tailor-made for each specific weighing task. The methods require users to always follow the same procedures according to the assigned SOP. The user can not deviate from this SOP, providing strict process compliance. Written instructions can be defined in the method to offer guidance to the user when the task is executed on the balance. This eliminates risk as all instructions are pre-set and users can simply follow the step-by-step instructions.

    With LabX, manual transcription error is a thing of the past, as all data are automatically captured. Key metadata, which are crucial to the weighing operation such as: weighing date and time, operator name, procedure used (during each weighing task), balance settings, weighing status and instrument used, and also when the balance was last adjusted are all recorded. Once the job is complete, a customized report can be generated that contains all necessary data for total compliance reporting needs.

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