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Where are you now? Intelligence Services > 21 CFR Part 11 > Products > Endotoxin Measurements > PyroLab > PyroLab

PyroLab 21 CFR Part 11 Compliant


PyroLab is a computer-integrated sample processing mini-workstation. It is a 21 CFR Part 11 compliant software solution product. The system is flexible and provides modular approach for various sample preparation steps. A unique part of PyroLab is the integrating software, which tracks and manages the sample processes.

Almost all analytical measurements start with sample preparation. Frequently these processes include purification of the sample by Solid Phase Extraction (SPE), concentration by evaporation, re-dilution in different solvents, etc. For the past decades expensive robotic systems have been utilized to mimic the analyst. Due to the high cost of these systems only large organizations have been able to benefit from the advantages of integrated automation. PyroLab has been designed to integrate both manual and computer driven steps for the sample preparatory processes.

Key Features

  • 21 CFR Part 11 compliance,
  • Low cost,
  • DQ-IQ-OQ-PQ integrated system validation protocols,
  • Modularity, flexibility, and scale-ability,
  • Increased productivity and reliability,
  • Seamless integration with other OPULUS products,
  • Easy integration with other application software.

PyroLab is created to integrate the following life cycle phases of sample processing:

  • Identification & description of the samples,
  • Identification of supplies & equipment used in the processes,
  • Pyrolytic cleaning and cleaning validation,
  • Generation of samplesí loading,
  • Weighing of samples,
  • Isothermal or programmed temperature treatment of samples,
  • Application of gas purging,
  • Application of vacuum,
  • SPE integration.

System Requirements (minimum):

  • Intel Pentium 200 MHz or compatible processor
  • 64 MB of memory
  • 150 MB free hard disk space
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • CD ROM drive
  • SVGA color monitor set to 800x600 graphical resolution with high color

System Requirements (recommended):

  • Intel Pentium II 500 MHz or compatible processor
  • 128 MB of memory
  • 200 MB free hard disk space
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • 1024x768 graphical resolution with True Color


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 PyroLab 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 PyroLab. Documentary proof of DQ compliance includes:

  1. Software Validation Plan,
  2. Software Validation Summary,
  3. 21 CFR Part 11 Validation Summary,
  4. Measurement Performance Design Summary, and
  5. Measurement Compliance Summary

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

  1. Receipt & acceptance checklist,
  2. Physical & electrical compliance checklist,
  3. Environmental compliance checklist,
  4. Training compliance checklist, and
  5. Final IQ Summary

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

  1. 21 CFR Part 11 operational specification checklist,
  2. Software operational specification checklist,
  3. Instrument interface operational specification checklist,
  4. Instrument operational specification checklist, and
  5. Final OQ Summary

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

  1. 21 CFR Part 11 compliance models,
  2. SQC models for instrument qualification review,
  3. SQC models for method qualification review,
  4. SQC models for vendor qualification review, and
  5. SQC models for OOS investigations

PyroLab Modules

21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

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