Where are you now? Regulatory Basis > 21 CFR Part 11 Issues > Compliant Products > Endotoxin Measurements > PyroDoQ
Over the last 10 years, kinetic LAL testing has become the most
powerful quantitative technique for highly sensitive & wide dynamic range
endotoxin measurement. Unfortunately, number of problems inherent in the system,
such as questionable signal specificity, signals mixed with hydrodynamic
disturbances (i.e., kinetic turbidimetric), and signal drift, have weakened its
utility and reliability, which can result in frequent retests and OOS.
DQ (Design Qualification) of a test system is a rare happening
in the laboratories. IQ, OQ, and PQ practices are routinely expected, but DQ is
another matter. What is DQ? DQ is the built in capability, let us say the
worst-case-scenario specification, of a test system. For example, signal
resolution, signal accuracy, and signal reproducibility are highly dependent on
the A/D resolution and the capabilities of the hardware-software design, such as
robust kinetics. Therefore, what should the specification of my test system
relative to the worst-case-scenario I have to meet? PyroDoQ will be able answer
PyroDoQ is based on highly accurate mathematical modelling of
LAL-endotoxin kinetic reaction. The model was evaluated & verified against
large number of actual - over 100,000 - test results.
- Simulation of a LAL-kinetic test conditions - LAL-kinetic curves can be
generated by the user relative to the following parameters: endotoxin
concentration in EU/ml, noise in dB, and outliers,
- LAL-kinetic model characterization - detailed information is provided
to understand the foundation of the simulation model,
- EndotogramTM and EndotographTM - improved interpretation of
LAL-endotoxin kinetic reaction pattern for signal specificity,
- Robust kinetics simulation - simulate the kinetic scan and observe the
results in 2D or 3D diagrams,
- Method development simulation & uncertainty analysis - method
development process & uncertainty in measurement are supported by
statistical analysis & graphical visualization, including best practices,
- SQC modeling of analytical parameters - evaluate the dependence of
critical quality criteria, such as PPC recovery, relative to the behavior of
standard curves, including, slope, intercept, and standard deviation,
- Knowledge about LAL-kinetics - update & improve your knowledge
about LAL-endotoxin kinetics; extensive HTML based information with embedded
simulation provides a rich knowledge base for better understanding of method
PyroDoQ offers rich set of models for DQ & method validation
of kinetic turbidimetric & kinetic chromogenic testing for broad set of applications, including:
- Pharmaceutical & biotechnology,
- Medical device,
- Clinical, and
You will be able to determine, which measurement system is
suitable for your testing requirements at the lowest possible cost.
- 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
- Internet Explorer 5.5 or later
- CD ROM drive
- SVGA color monitor set to 800x600 graphical resolution with high color
Regulatory compliance in the pharmaceutical, biotechnology, and
medical device, industries is the foundation of good business practices.
DQ-IQ-OQ-PQ documents for PyroDoQ provide significant support to reduce the risk
DQ (Design Qualification) - DQ supports the functional
& quality specifications designed into PyroDoQ. Documentary proof of DQ
- Software Validation Plan,
- Software Validation Summary,
- Simulation Performance Design Summary, and
- Simulation Compliance Summary.
IQ (Installation Qualification) - IQ supports the
requirement for proper installation and acceptance qualification for PyroDoQ.
Documentary proof of IQ compliance includes:
- Receipt & acceptance checklist,
- Training compliance checklist, and
- Final IQ Summary.
OQ (Operational Qualification) - OQ supports the
specification compliant functioning of the system. Documentary proof of OQ
- Software operational specification checklist, and
- Final OQ Summary.
PQ (Performance Qualification) - PQ supports quality
evaluation & quality compliance management of the system. PQ compliance
- SQC models for method qualification review.