Your Complete

Software Solution For

Endotoxin Testing

and Reporting

• Intuitive

• User-Friendly

• Compliant

• Reliable

Pyros® EQS is a sophisticated 21 CFR Part 11 Compliant, complete software solution that

provides efficient, accurate endotoxin testing analysis and reporting. The software, which

interfaces with an Oracle® database, has multiple, administrator-controlled user access levels

for improved security, detailed audit trails with built-in trending by data groups, sample type,

technician, instrument type and LAL reagent lot number.

Intuitive and easy to use, the Pyros® EQS software was designed by engineers and researchers

specifically for endotoxin testing. The software provides enhanced reporting options, flexible

operation modes and incorporates electronic signatures, as well as a supervisor sign-off

on completed tests, two choices for calculating Coefficient of Variation (CV), and a new,

summarized Pass/Fail Report.

Bacterial endotoxin testing, using Limulus Amebocyte Lysate (LAL) reagents, is one of the

most critical quality control procedures for parenteral drug and medical device lot releases.

Pyros® EQS is a purpose-built software application designed to support tube reader-based LAL

testing. Combined with our Pyros Kinetix® Flex incubating tube reader and a choice of kinetic

chromogenic or turbidimetric reagents, we offer a complete system for efficient and accurate

endotoxin testing in compliance with the USP, EP and JP bacterial endotoxins test chapter. Pyros®

EQS software has been developed to provide ease of use, comprehensive documentation,

and full regulatory compliance. Its Oracle® database offers storage that is limited only by your

storage hardware and the built-in audit trail provides detailed documentation

of all data settings and modifications. Security has been assured

by full administrator-defined requirements

for authenticated access and read-write

privileges to data groups and files. Test set up

and data entry is easily configured based upon

stored templates. Output is customizable

and can be exported to your preferred

reporting applications.

With Pyros® EQS, the LAL testing

community can be assured

that their data is accurate,

secure, reliable and compliant.

Product Features & Benefits • 21 CFR Part 11 Compliant

~ Meets regulatory compliance requirements of the FDA

• Runs on Oracle® Database

~ Unlimited data storage on the pharmaceutical industry

standard database

~ Secure storage and back-up utilizing Oracle supplied functionality

• Choice of network client-server or stand-alone workstation

configuration

~ Flexibility to meet the needs of small to very large laboratory

configurations

• Enhanced Reporting Options, including the ability to export to

MS Word®, Excel®, Crystal Reports® and Adobe® .pdf file formats

~ Variety of template formats for ease of reporting

• Runs Multiple Standard Curves

~ Ability to run endotoxin potency determinations

~ Ability to rapidly readjust the standard curve to meet sample range

• Flexible Operation Modes

~ Background data collection permits other applications to run

while collecting data

~ Data collection continues locally, even if network connection

to database is lost

• Designed for use with either the Pyros Kinetix® or

Pyros Kinetix® Flex Tube Reader

~ Broad Sensitivity Range: As high as 0.001 EU/mL with

chromogenic and turbidimetric assays

~ Individually timed reactions; allows for continuous addition

of samples during operation

• Easier, more user-friendly installation

~ Auto-installs any prerequisite applications

Intuitive, user-friendly interface provides access to all functions of the software.

Customize your reports by adding a company logo.

Real-time monitoring of reaction wells allows users to troubleshoot sample behavior and assess ongoing assay performance.

Dynamic Reporting Options

Corporate Headquarters Associates of Cape Cod, Inc.

124 Bernard E. Saint Jean Drive, East Falmouth, MA 02536-4445 USA Tel: (888) 395-ACC1(2221)

custservice@acciusa.com • www.acciusa.com

United Kingdom Associates of Cape Cod Int’l., Inc.

Deacon Park, Moorgate Road, Knowsley, Liverpool L33 7RX, UK Tel: (44) 151-547-7444

info@acciuk.co.uk • www.acciuk.co.uk Company Registration Number: BR002906

Germany Associates of Cape Cod

PYROQUANT DIAGNOSTIK GmbH Opelstrasse 14, 64546 Mörfelden-Walldorf, Germany

Tel: (49) 61 05-96 10 0 service@pyroquant.de • www.pyroquant.de

Pyros® and Pyros Kinetix® Flex are trademarks of Associates of Cape Cod, Inc. All other trademarks mentioned are the property of their respective owners.PN002332 Rev2