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Where are you now? 21 CFR Part 11 Compliant Products > PyroButton > PyroButton - BT

Data-Loggers - PyroButton-Basic 21 CFR Part 11 Compliant

Opulus is a Dallas Semiconductor Authorized Solution Developer





Introduction

PyroButton - Basic (Basic Temperature) is member of category of products of wireless sensor based devices designed to work independently or in an integrated network for monitoring of warehouses, refrigerators, freezers, processing facilities, transportation containers, laboratories, stability chambers, equipment, or you name it.

PyroButton - Basic has been developed to provide an efficient & cost effective solution for wireless temperature monitoring. The system integrates iButtonTM technology from Dallas Semiconductor with simple-to-learn & easy-to-use software based on HTML wizard navigation.

Environmental conditions play a critical role in the quality outcome of products. Real-time monitoring of the parameters offers an effective way to assess specification characteristics, such as temperature, and intervene preventively. PyroButton - Basic supports more efficient and effective control of critical limits, than spot-checks of the environment and batch testing of the products. Furthermore, electronic record-keeping allows evaluation and re-evaluation of CCP (Critical Control Point) and efficient compliance to HACCP & GxP regulations.

Key Benefits to the User

  • Each data-logger is calibrated at 5 different temperatures & the calibration is verified prior to shipment
  • Calibration corrections can be automatically calculated for each temperature measurement in PyroButton-ST
  • Certificate of Calibration is included for each data-logger
  • The data-loggers can be chemically sterilized & depyrogenated due their hermetically sealed stainless steel housing
  • High Throughput Adapters are available, which hold 8, 16, 32, or 50 data-loggers for simultaneous programming or downloading of data
  • The data-loggers can be integrated to wireless communication network for global data management
  • The data-loggers can be integrated to computer designed temperature mapping for cost effective and compliant validation & monitoring
  • Data-acquisition simulation ensures optimized battery life span
  • PyroButton is easy to learn and simple to operate

Return-On-Purchase-Investment (ROPI)

  • Low purchase cost ensures rapid Return-On-Purchase-Investment
  • Low calibration cost ensures low cost of compliance
  • Low maintenance cost ensures low cost of operation
  • On-line training ensures low cost of implementation
  • 21 CFR Part 11 compliance ensures investment security

Key Features

  • 21 CFR Part 11 Compliant system
  • Smallest wireless industrial data-logger (17mm by 6mm or 2/3in by 1/4in)
  • Rugged stainless steel casing protects the sensor from water, shock, and contaminants
  • Broad range of accessories are available for attachments
  • The data-loggers can be sterilized & depyrogenated
  • Unique - global - identification is provided for each wireless data-logger
  • Typical battery life-time is 9 years
  • Software life expectancy modeling and usage optimization
  • RS232, USB, & parallel adapters are available for programming & download
  • Temperature resolution up to: 0.1°C
  • Calibrated temperature accuracy up to: 0.1°C
  • NIST traceable calibration
  • Programmable data acquisition rates from 1 read/sec. to 1 read/255 min.
  • Programmable starting time from 0 to 45 days
  • Internal memory holds 2048-8096 temperature data with roll-over option
  • Control charts with 2-levels of limits can be defined
  • Histograms provide temperature frequency classification
  • Excel compatibility
  • XML compatibility
  • Integrated wizard navigation ensures easy learning
  • IQ-OQ-PQ protocols
  • 21 CFR Part 11 verification protocol

System Requirements:

  • Windows 98, Me, NT 4.0, 2000 or XP operation system
  • CD drive
  • Mouse
  • Free serial or USB port
  • MS® Internet Explorer 6.0

For more detailed information, please visit www.pyrobutton.com


DQ-IQ-OQ-PQ and 21 CFR part 11

Regulatory compliance in the pharmaceutical, biotechnology, and medical device, industries is the foundation of good business practices. DQ-IQ-OQ-PQ documents for PyroButton provide significant support to reduce the risk of non-compliance.

DQ (Design Qualification) - is the foundation of good science & good compliance practices. You cannot get more out of a system that has been built into it. DQ is the tool & methodology to make the evaluation of suitability for specific requirements, including worst-case-scenario. DQ also provides the baseline for meaningful Performance Qualification (PQ) monitoring; without DQ, PQ flounders, it does not exist. 21 CFR Part 11 compliance is a major functionality relative to Design Qualification.
In the first part let us consider what may be the most important questions to ask relative to 21 CFR Part 11 DQ. STOP

DQ supports the functional & quality specifications designed into PyroButton. Documentary proof of DQ compliance includes:

  • IQ-OQ-PQ protocols
  • 21 CFR Part 11 Verification Summary,
  • Measurement Performance Design Summary, and
  • NIST Traceable Calibration Summary


IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for PyroButton. Documentary proof of IQ compliance includes:

  • Receipt & acceptance checklist,
  • Physical & electrical compliance checklist,
  • Environmental compliance checklist,
  • Training compliance checklist, and
  • Final IQ Summary


OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:

  • 21 CFR Part 11 operational specification checklist,
  • Software operational specification checklist,
  • Instrument interface operational specification checklist,
  • Instrument operational specification checklist, and
  • Final OQ Summary


PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:

  • 21 CFR Part 11 compliance models,
  • Simulation models for data-acquisition optimization, and
  • SQC models for measurement qualification review.


21 CFR Part 11 Issues
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