PyroDoQ

• Introduction
• Key Features
• Applications
• System requirements
• DQ-IQ-OQ-PQ
• What´s in the box?
• FAQ
• Installation guide for PyroDoQ
• How can I purchase PyroDoQ?

Introduction

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 your questions.

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.

Key Features

• 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,
• Endotogram^TM and Endotograph^TM - 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 development requirement.

Applications

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
• Environmental.

You will be able to determine, which measurement system is suitable for your testing requirements at the lowest possible cost.

System requirements

• 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

DQ-IQ-OQ-PQ

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 of non-compliance.

DQ (Design Qualification) - DQ supports the functional & quality specifications designed into PyroDoQ. Documentary proof of DQ compliance includes:

1. Software Validation Plan,
2. Software Validation Summary,
3. Simulation Performance Design Summary, and
4. Simulation Compliance Summary.

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

1. Receipt & acceptance checklist,
2. Training compliance checklist, and
3. Final IQ Summary.

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

1. Software operational specification checklist, and
2. Final OQ Summary.

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

1. SQC models for method qualification review.