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Fungitell'",Pyros'" and Pyros Kineti"" aretrademarksof Associates of CapeCod, Inc.

All other trademarksmentioned arethe propertyof their respective owners.

Trend DataPyros® EQS includes powerful features for reviewing historical data.

Results can be plotted by user,sample type, technician IDreagent lot number orinstrument ID to enable trendsto be identified and evaluated.Trending reports are easilygenerated by accessing theTrend Data Report Parametersscreen and selecting theappropriate datadelimiters. Theoutput format can be selectedas either report or plot byclicking a graphical button onthe screen (figure 4).

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levels of reports. These include separate reports for Assay, System, andUser information. Also, a Custom audit trail maybe selected in whichthe user can create a reportbased uponselected elements from the firstthreecategories (figure 3). All of these features areeasily accessible byselecting the Audit Trail button on the main screen.

figure 3

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In conclusion, Pyros® EQS is a sophisticated, secure, and stableapplication. Pyros® EQS with the Pyros KinetiX® tube reader cometogether to provide a highly flexible system that is custom built for

endotoxin testing with the greatest sensitivity available. III

User ManualUsers will appreciate the very detailed explanations andinstructions thatareprovided in the User Manual binderthat isprovided with Pyros® EQS.In addition to the hard copy, an electronic copy may be viewed byclicking the Help button in the main screens. The manual provides user-friendly explanations of all of the Pyros® EQS functions. An appendixprovides detailed explanations of the underlying mathematical operationsthat support the determinations of endotoxin concentration.

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Security features include a Global User Identifier or "GUID" assigned toeach completed and signed off test. This is listed in the Report ID forcompleted andsigned off reports. Anychange to anyaspect of the testor the report will cause the "GUID" to change. This allows easydetermination of any changes to a completed test report. Backing thisup is a comprehensive Audit Trail function that will track key changesmade (see below).

Robust Internal Quality ChecksPyros® EQS offers users multiple levels of tests for assay validity. Theseallow users to determine, at a glance, whetherthe test results meetthepre-set requirements for validityand whetherany results areOutOf Specification. Two types ofelements are evaluated todetermine test validity. The firstcategory involves basic systemfunctionand addresses elementssuch as instrument temperature,optical density artifacts, tuberemoval and data transmissionerrors. The second categorycomprises of what are calledConditional Tests. These involveverification that assay-derived figure 4values meet their pre-determined, often user-defined, criteria. Theseinclude the following: correlation coefficient, negative control validity,CV limit for standards, CV limit for samples, positive control recovery,range of positive product control recovery, and endotoxin limit.Detailed explanations of these self-check functions are given inthe User Manual.

Data Security and User Rights ManagementUser access control and data security are key requirementsfor laboratories performing tests under GMP and the requirements of21 CFR Part 11. Pyros® EQS permits the assignment of multiple levelsof access rights. These are administrator, supervisor, and technician.Administrator-level users may set up data-groups, data-group access,and read andwrite permissions for the other two levels. By setting updata-groups within the database, administrators can partitiondata, andaccess to that data, by product type, department, facility, etc. Onlythose individuals with specific privileges can access, create, and/ormodify datawithin those data-groups. This is accomplished through asimple on-screen process using the User and Data Group Managementdialog box. Certain key functions are restricted to administrator-levelusers. These include the establishment of new test settings, testinformation attributes, and the modification of the test parameters. Inaddition, the signing off of completed tests isrestricted to administratorsand designated supervisors.

Audit TrailA robust and secure audit trail is a key feature for compliance with 21CFR Part 11. The Pyros® EQS audit trail function is comprehensive andallows users to feelconfident in their abilityto ensure both the integrityof their dataand regulatory audit compliance. The audit trail functionrecords keytest,system, anduser information andall importantchangesto them. Additionally, the user can entercomments such as reason forchange, in order to ensure that valuable information to explain whychanges weremade iscaptured. The Audit Trail feature offersusers four

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