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Validator ® 2000

Benchmark Thermal Validation System

The Validator 2000 is a standalone thermal validation solution specifically designed to conform with new FDA data protection guidelines (21 CFR Part 11) and meet international and European cGMP requirements for inspection of pharmaceutical, biotechnology and medical device (EN285, EN554) manufacturing. The Validator 2000 simplifies the entire validation process by reducing setup time and minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports.

Kaye Validator 2000

Meets FDA guidelines for protecting electronic data (21 CFR Part 11)

  • Prevents unauthorized access via user ID and password for critical operations
  • Creates secure results using files that cannot be used if tampered with
  • Creates printed or spreadsheet reports from a single protected file.
  • Creates comprehensive audit trail of all actions affecting user data.

Raw data is never modified

  • Protects data with internal memory if floppy disk fills up or printer runs out of paper
  • Saves data with battery back-up for up to 30 minutes if system loses power
  • Plug-in Sensor Modules minimize sensor handling and save calibration time
  • Eliminates the need for quick disconnects on each input
  • Stores calibration offsets, allowing the software to link module with a specific instrument. From storage to instrument, sensors are ready for immediate use.

Most importantly, the Validator 2000 features a report generator that enables the grouping of calculations into customized, easy-to-read reports. The system organizes the test data in a spreadsheet format, saving analysis time and speeding access to critical process data.

Flexibility to operate standalone or with PC during testing

  • Calibrates sensors and runs qualification studies with or without a PC
  • Provides easy-to-read data for up to 12 sensors per screen with menu-prompted displays
  • Enhances viewing on PC screens such as trending of live data

More flexibility to setup your test

  • Separates sensors in up to four groups, e.g., independent reports for distribution and penetration or for qualifying multiple chambers
  • Headers and comments are unique for each group
  • Sets conditions for automatic starting and stopping of exposure and qualification
  • Calculates lethality using base temperature, Z and D values
  • Provides condition of lethality calculation based on chamber pressure
  • Includes interval min., max., avg., and standard deviation calculations

Save time analyzing data

  • Generates new spreadsheet formatted reports for each group: easy to read
  • Creates Summary report to view test results at a glance
  • Simplifies tracking of validation data since all results of Setup, Calibration and Qualification are kept in a single protected file
  • Prints reports individually or all at once
  • Locates files quickly because they are saved by descriptive name,author and date
  • Monitors critical events and generates messages
  • Trends inputs and calculations on-line

No more hassles to document exceptions

  • Eliminates need to circle exceptions, write comments by hand, or use spreadsheet software to recalculate data
  • Documents a failed sensor, but user can exclude bad data from calculations
  • Captures user comments as part of standard report

And there is much more...

  • Accepts up to 36 inputs in any combination of thermocouple, voltage or current inputs
  • Provides total system accuracy of
    0.28°C with improved noise immunity
  • Meets European requirements for fast data storage of one sample per second
  • Supported by fully validated hardware, software and firmware documentation
  • Simplifies your SOP development using 22-page standard operating procedure on disk
Kaye Validator 2000

The Validator 2000 comes with a comprehensive 1-year warranty. With its built-in floppy disk, softwar upgrades are easy. There are no components to install, even for updates to the firmware. And the system is fully validated.

Learn first-hand how the Validator 2000 can simplify your process validation needs.

Click here to download more information on high quality Kaye validation equipment. To request printed literature or quotations, click here, call Sales at 1-800-833-9438 (US and Canada) or, contact your local sales representative.

Validator® 2000 Documentation

SOP for Validator 2000 Customers -- Saves Time

Here is a time-saving document for customers who need to create a standard operating procedure (SOP) for the Validator 2000. You can download it for FREE. The 22-page SOP describes all validation components, procedures for wiring, operation, calibration, report generation, and more. Download the file and modify it to suit your requirements. Go to download page.

Validator 2000 IQ/OQProtocol

This document defines a set of procedures to ensure that the Validator 2000 and it's associated components are properly installed and operated according to Kaye recommendations and adequately documented and controlled according to cGMP requirements. The documents are also provided on CD as part of the package allowing you to modify them to suit your organization.

Kaye Validator 2000 Validation DocumentationThe package contains the following

  • Installation Qualification Document
  • Operational Qualification Document
  • Standard Operating Procedure Document
  • Document files on CD in MS Windows, Word 97
  • Set-up programs are also included on the CD. These setups are part of the testing for the Operational Qualification.

To request a quote for this product (X6005), email us at sensing@ge.com.

Validation Reference Guide

Kaye supports the Validator® 2000 hardware and software as a validated system with published documentation. Individually serialized, the Validator Reference is designed to help you meet your validation system audit and vendor qualification requirements - while saving the time and expense of conducting an audit at Kaye.

The reference provides an overview of the Kaye Quality Policy, describing the ISO 9001 implementation. Included are the procedures and standards for development, testing, and maintenance of hardware and software. The Reference contains:

  • Functional specifications
  • Test plan procedures with test documentation
  • Change procedure with problem reports
  • Release notes and engineering change orders
  • Testing and QA acceptance.

The finished document is a summary of information you would obtain from an audit at Kaye - and at a much lower cost. As a registered user, you are notified when subsequent updates are published to ensure your reference stays current.

To request a quote for this product (X6000), email us at sensing@ge.com.


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