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Reports

The Kaye RF ValProbe Software includes an intuitive,

yet powerful reporting utility for generating Set-Up,

Calibration, Qualification, Graph and Calibration

Verification reports to document validation study

results. Reports are generated from secure data files

that can only be read by the system software. Upon

study completion, process cycles to be analyzed are

defined using the intuitive system graphic feature.

Qualification

Reports present raw process data for individual

sensors, statistical calculations selected during study

setup, and accumulated lethality for individual sensors.

Summary reports present study set-up details and

poststudy user comments, along with group interval

and lethality calculations, as well as data for each

group and cycle. Use of the Summary and Group

Summary Reports can greatly reduce the need to

Any action affecting user data can be permanently

captured in a comprehensive audit trail, which

can be automatically stored at a network location.

System administrators can now have fully automated

management of passwords, audit trails and data files

across all validation groups.

Summary Report

Data files can be merged from multiple RF ValProbe

and ValProbe studies. Users can add unlimited cycles,

separating qualification data into specific process

phases, and create up to 25 groups with their own

calculations and graphs during reporting,

A powerful graphing utility within the system software

greatly simplifies process analysis and reporting. Sliding

verticalaxesenabletheoperatortoflaganddefine

process transition points, eliminating unnecessary

reporting and streamlining the review process. The

graphutilityfeaturesincreasedflexibilityforgraph

customization, including specifying X and Y axis ranges,

background colors, line styles and labeled limit lines.

Graph report

Security, Passwords and Audit Trails

The Kaye RF ValProbe is specifically designed to enable

compliance with FDA 21 CFR Part 11. All recorded data,

including calibration offsets, set-up parameters, and

administrative tasks are saved in secure, encrypted,

tamper-proof electronic records in a format accessible

only through the system software.

All user inputs which could impact user data, for

example starting a study or running a calibration, are

protectedviasecureusername/passwordlogins,and

are all logged in the secure audit trail database.

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