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.
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