OPULUS
Welcome Guest (Log in, Subscribe
 What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription 


Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

Search: 


Adobe Acrobat Reader

PyroSolution - FAQ

   






  1. What is PyroSolution?
  2. What is Sample Tracking?
  3. What is a EQU & EQUAL?
  4. How does EQUAL work?
  5. Does PyroSolution support electronic signatures (21 CFR Part 11)?
  6. What kind of database does PyroSolution use?
  7. Is PyroSolution capable of performing kinetic and endpoint measurements?
  8. What are robust kinetics?
  9. What is Signal Processing?
  10. Why do I need signal processing during LAL-endotoxin kinetic testing?
  11. What do I need to know to utilize the signal processing capability in PyroSolution?
  12. Does PyroSolution support suitability evaluation for raw data quality?
  13. What is outlying point or outlier?
  14. What is "noise"?
  15. What is curve smoothing?
  16. Am I limited to OD limit calculations only in PyroSolution?
  17. What kind of readers does PyroSolution support?
  18. Does PyroSolution support documentation of the reagents, supplies and equipment used during a measurement?
  19. How can I use OOS database & OOS management?
  20. Is PyroSolution validated?
  21. What kind of support will I receive after purchase?
  22. Why should I buy PyroSolution?
  1. What is PyroSolution?
    PyroSolution is an Endotoxin Information Management System with integrated capability for method validation, multiple instrument control for parallel measurements, and sophisticated decision making to control, monitor, evaluate, and prevent endotoxin contamination.
  2. What is Sample Tracking?
    Sample Tracking is a configurable application capable of registering, storing and managing data related to samples. Sample Tracking is seamlessly integrated with PyroSolution for effective SPC & OOS management.
  3. What is a EQU & EQUAL?
    EQU is an Application Integration System. It is a natural language SQL, modeling, & visualization development system, that can be connected through standard protocols to databases. EQU ActiveX with application packages is called EQUAL. EQUAL can be embedded into other applications.
  4. How does EQUAL work?
    EQUAL models are natural language SQL sentences. Each model contains one ore more sentences with embedded parameters. The parameters may be defined by the user to obtain results in the form of tables & graphs about the model. EQUAL within application environment can generate thousands of decision models.
  5. Does PyroSolution support electronic signatures (21 CFR Part 11)?
    PyroSolution has electronic signature capability and complies with 21 CFR Part 11 requirements. No buts and ifs.
  6. What kind of database does PyroSolution use?
    PyroSolution uses MSSQL 7.0 database for fast and secure access. Database access can be configured during the installation/reinstallation procedure.
  7. Is PyroSolution capable of performing kinetic and endpoint measurements?
    Yes. PyroSolution is suitable to design and execute both kinetic and endpoint measurements.
  8. What are robust kinetics?
    Kinetic turbidimetric tests have gained in prominence due to their relatively low cost, high sensitivity, and wide dynamic range. However, practical experience has indicated critical reliability problems due to bubbles in the solutions and variations in turbidity. Kinetic-scan coupled with suitable algorithms, i.e., robust kinetics, can improve the viability of turbidimetric tests.
  9. What is Signal Processing?
    Signal Processing (SP) is a set of complex mathematical operations on digital signals to improve the reliability of the raw data.
  10. Why do I need signal processing during LAL-endotoxin kinetic testing?
    Signal processing improves specificity, accuracy, reproducibility, and reduces OOS. In the case of LAL-endotoxin testing very low levels of signals are utilized at the lowest concentration points, which are especially vulnerable to disturbances and false signals, such as noise & drift.
  11. What do I need to know to utilize the signal processing capability in PyroSolution?
    Nothing. Use PyroSolution's default settings.
  12. Does PyroSolution support suitability evaluation for raw data quality? Yes. Raw data quality checks include:
    Data saturation check: checks whether the maximum OD value of the signal is under the preset OD limit (i.e., reader's maximum OD value).
    Check minimum number of measured points: checks the number of measured points required for evaluating the data.
    Check minimum dynamic range: checks the minimum dynamic range requirement for the evaluation.
  13. What is outlying point or outlier?
    An outlying point is a statistically defined exception to a trend determined by the other points.
  14. What is "noise"?
    "Noise" is the standard term used to describe random electronic signals detected by a reader. The relationship between the useful signal and noise is characterized by the signal-to-noise ratio (S/N ratio). A low signal-to-noise ratio (where the noise component is high, relative to the useful signal) may necessitate retesting. The unit, used to describe the quality of a signal, is the decibel (dB). Signals of 30 dB or below are too noisy to be useful.
  15. What is curve smoothing?
    Curve smoothing is a mathematical operation to improve the signal to noise ratio of a curve (i.e., reducing the effect of noise).
  16. Am I limited to OD limit calculations only in PyroSolution?
    No. PyroSolution has three different calculation methods to evaluate the kinetic measurement data:
    1. OD limit method: calculates the reaction times at the pre-selected OD limit. Traditional method.
    2. Inflection point method: calculates the reaction times at the inflection points of the curves. New method!
    3. Rising edge method: calculates the reaction times from the rising edges of the curves. New method!
  17. What kind of readers does PyroSolution support?
    1. BioTek - Ceres900
    2. BioTek - PowerWave
    3. AsysHitech - Digiscan-T
    4. BioTek - EL340
    5. BioTek - EL808
    6. BioWhittaker - Kinetic QCL
    7. Anthos - HTIII
    8. Labsystem - Twinreader
  18. Does PyroSolution support documentation of the reagents, supplies and equipment used during a measurement?
    Yes. All of the information including unique IDs are stored in the SQL database and can be used in SQC modeling & vendor qualification.
  19. How can I use OOS database & OOS management?
    If OOS observed, then prior to final approval and release of the results each and every part of the analysis can be reviewed and re-evaluated for compliance. Observations can be attached to each step and/or component of the measurement. EQUAL can provide complete support for rapid & full scale OOS investigation.
  20. Is PyroSolution validated?
    Yes. You will receive as part of DQ: Software Validation Plan, Software Validation Summary, and 21 CFR Part 11 Validation Summary.
  21. What kind of support will I receive after purchase?
    PyroSolution package includes extensive documentation, including:
    1. Installation Guide.
    2. User Manuals - PyroSolution, Sample Tracking, User Manager, & EQUAL.
    3. Getting started CD - PyroSolution, Sample Tracking, User Manager, & EQUAL.
    4. DQ-IQ-OQ-PQ
    5. 24/7 Web-training
    6. 24/7 Web-Technical support
  22. Why should I buy PyroSolution?
    Fully compliant with 21 CFR part 11 software requirements; NO BUTS & IFS. PyroSolution includes unique capabilities, that NO other competitor is able to claim:
    1. Signal processing integration
    2. Robust kinetics
    3. OOS-database & OOS management
    4. PyroWiz wizard integrated with HTML for multiple languages
    5. SQC & SPC models, that can be extended to Data Mining
    6. Configurable sample management & sample tracking
    7. Configurable application for pharmaceutical, clinical, & environmental testing
    8. Smart method validation with uncertainty analysis
    9. Endotogram & Endotograph analysis

 

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

back Back
----------------------------------
--| What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription |--
© 2001-2003 OPULUS® is licensed to BioMondex Ltd. All rights reserved. Please read the disclaimer.