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Last modified: 2018-01-18 
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Calibrations/Calibrators

PyroButton & iButton Calibration Service Management

Introduction

PyroButton/iButton temperature data-loggers are calibrated at the minimum of 5 points prior to shipment. The calibration values, uncertainty of calibration, and calibration curves are transferred to the applicable programs - PyroButton-SQL - for appropriate correction of temperature and humidity measurements. In addition of the correction factors, administrative details and statistical analysis of the calibrations are also provided.

To maintain consistent accuracy, reproducibility, reliability, and regulatory compliance, calibration and/or calibration verification must be performed of the data-loggers at suitable intervals (i.e., at least once a year). Meaningful calibration (see, Good Calibration Practices) can also provide insight into quality characteristics of the devices. For example, Using EQUAL Decision Support Sub-system of PyroButton-SQL, Performance Qualification of the calibration can be evaluated and the monitoring system can be optimized relative to:

  • Accuracy, reproducibility, and reliability
  • Calibration Needs Analysis
  • Preventative Maintenance Analysis of the data-loggers
  • Failure prediction of the data-loggers
  • Compliance Management.

The benefits of a single integrated solution include:

  • Full integration & automatic data transfer between the calibration system & the application programs, including PyroButton-SQL
  • Consistent compliance with 21 CFR Part 11 across the measurements
  • Consistent calibration correction procedure across the data-loggers
  • Comparative analysis of the calibrated devices
  • Consistent quality management relative to calibration performance
  • Consistent calibration maintenance & recalibration of the devices
  • Calibration Needs Analysis scheduling
  • Effective & efficient OOS, OOT, & CAPA compliance
  • Highest Return-On-Investment

Each calibration record contains:

  • Certificate of Calibration ID
  • Calibration Reference ID
  • Dates of calibration with QC/QA approval
  • Calibration SOP
  • Results of the calibration for both the reference and the calibrated device
  • Statistical evaluation, including uncertainty of measurement calculations
  • Next date of scheduled calibration

Results and relevant IDs of the calibration are exported to PyroButton-SQL. In case of PyroButton-SQL Statistical Quality Control models can monitor the calibration Performance Qualification (PQ).

Key Benefits to the User
  • Integrity testing performed on each data-logger prior to calibration
  • Full compliance to the regulations, including
    • 21 CFR Part 11
    • IQ-OQ-PQ
  • Improved accuracy
  • Integrated Performance Qualification monitoring of the data-loggers
  • Scheduling of calibration
  • On-line competency training of the calibration
  • OOS, OOT, & CAPA investigations support









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