TQSoft™ Spec Checklist

EN554, EN285, EN15883, HTM2010, HTM2030, 21CFRpart11, AMS2750

Please visit Compatibility page for loggers & calibration hardware supported.

Security & 21CFR Part 11

• Login window with ID & password
• Password timeout & Renew
• Electronic Signatures on Reports
• Security Data is encrypted
• Complete Audit Trail detailing Change History
• Complete Audit Archive & Retrieve Changes Option
• Security Management Window
• Operator Profile Management
• Operator Timeout & Password length & timeout Controls
• Data Files Tamper Proofing

Calibration & Calibration Checking

• Select calibration file to store results
• Select channel groups for calibration
• Allow a test to use sensors calibrated in different groups
• User managed calibration stability and set point profile
• Automatic calibration option with automated stability analysis procedure
• Calibration progress monitor window with adjustable reference temperature for manual calibration
• Abort option
• Detailed comprehensive calibration reports stored & archived with management window
• Automatic management of calibration files. Test records are automatically assigned all relevant calibration reports for sensors used.
• Out of specification channels highlighted and when used in a test automatically set to defective
• Automatic management of calibration checking files. Test records are automatically assigned all relevant check reports for sensors used.

Test Specifications

• Allow user to create unlimited Test Specification files
• Allow new file to start with copy of existing one
• General Settings tab allows selection of:
  • channel configuration file
  • calibration file
  • sterilization/disinfection temperature
  • scan interval
  • automatic stop options
  • stage analysis (for HTM2010)
  • continuous monitoring options
  • selection of time format
  • chart configuration
  • data list configuration
• Calculations tab allows setup of calculations based on each row of data:
  • Max per scan
  • Min per scan
  • Average per scan
  • Max - Min per scan
  • Max - Average per scan
  • Average - Min per scan
  • Min Lethality per scan
  • Saturation temperature
  • Saturation pressure
• Lethality tab allows configuration of lethality calculations:
  • Base temperature & Z value
  • Probe group
  • Start lethality on temperature or stage
  • End lethality on stage
  • Temperature/Pressure correlation limit with reset option
  • Option to use lethality config on time at temperature calculations
• Probe selection allowing location entry
• Setup of stages for manual entry during the test
• Setup of parameter specific to logger selected (eg TMI-ORION)
• Test Specification file is copied to test record for access historically as Test Detail
• Historic changes do not affect Test Specifications on Setup menu
• Test records have Test Setup report of Test Specification parameters
• Historic tests can be re-analysed after fully audited changes to historic test specification
• Channels can be set or unset to or from defective state
• Channels set as defective are not reported or included in any calculations

Test Specifications I-Calcs

• User configurable Interval Calculations
• User managed list window
• Allow I-Calc duplication
• Allow I-Calc copy to another Test Specification
• Select purpose of I-Calc:
  • Chart line
  • Stage or message insert
  • Continuous limit monitoring
  • Calculation on Interval
• Select group of probes
• Calculations available:
  • Selectable groups
  • Selectable Interval
  • Selectable Limits
  • Set IO on Limit
  • Set Message on Limit
  • Set Report colour on Limit
  • Select where calculation appears
  • Set insert stage event on Limit
  • Interval Duration
  • Time at Temperature
  • Max probe value
  • Min of Maxs.
  • (Max - Min) Of Maxs.
  • Min probe value
  • Max of Mins.
  • (Max - Min) Of Mins.
  • Average probe value
  • Max Average
  • Min Average
  • Fluctuation
  • Max Fluctuation
  • Max Deviation
  • Max lethality
  • Min lethality
  • Lethality Deviation
• Allow entry of limit values:
  • Target value
  • Upper limit
  • Lower limit
  • Hysteresis
• Allow entry of actions:
  • Message to show on chart and/or data list
  • Insert message at offset from actual time I-Calc is triggered
  • Highlight on failure
  • Hide on chart or data list option
  • Digital IO ON/OFF
  • Display screen message

The Data List

• Highly detailed and configurable Data Listing option
• Displays stages and I-Calc actions & results
• Summary option allows data to be printed at intervals configured for each stage
• Data List can be dragged & resized
• Landscape or portrait option
• Prints data in configurable colors according to value
• If too many channels for one line, data is formatted to fit paper
• All calculations can be shown
• Electronic signature option

Calibration Files

• Allows multiple calibration files selected on user managed names
• Option to switch off calibration
• Select from names for calibration function
• Contains last calibrated date, time, pass/fail etc details for each channel

The Chart

• Chart is fully configurable
• Setup margins for printout
• Setup range for each unit
• Setup number of grid lines
• Setup trace thickness
• Real time chart all functions operational
• Displays stages and I-Calc actions
• Shows two vertical axis ranges, one temperature, the other non temperature (any units)
• Chart can be dragged & resized
• Chart displays trace ID at customizable interval
• Mouse pointer on chart shows values & time value at location
• Data line option shows values & time at sliding line
• Easy stage entry option at data line position
• Zoom into any area and the zoom in again
• Chart printout includes trace ID table

Company Name & System ID & Options

• User name heading all reports
• Configuration file ID tag for group users
• Selectable date format

Historical Test Storage & Retrieval

• All tests are stored in separate machine folders
• Each test has entry in Historic Test Index
• Test Index refresh option scans specified folder and all sub-folders for stored tests and creates new list
• Historic Test List can be configured to show any number of test data fields
• List can be filtered and sorted on date and time
• List can be configured for ‘tree view’ mode to group tests according to any field (eg hospital site)
• Next and previous buttons sequences through tests updating the chart window with next record

Data Management & Archiving

• Data Management window:
  • Allows selection of multiple Tests, Calibration records, Calibration Check records, or user configuration files
  • For user configuration files user can further select the type of files
  • Report on space requirement
  • Allows selection of drive or network location for copy target
  • Stores an ID on the target
  • Reports space available on target
  • Allows selected files to be copied and or deleted
• Archive window allows:
  • Target drive or network location selection
  • Automatic archiving option at end of test or calibration
  • Real time archiving as test is being logged
  • Start button for archive process
  • Shows progress of archive process
• When archiving only changed or new files are transferred

Machine Records Database

• User managed database of equipment or facilities tested with custom fields
• Select machine for each test
• Information automatically copied to test records
• Fields can be used in TQExpress Custom Forms
• Filter records

Calibration Files

• Allows multiple calibration files selected on user managed names
• Option to switch off calibration
• Select from names for calibration function
• Contains last calibrated date, time, pass/fail etc details for each channel

Test Equipment Database

Store all information on Test Equipment in database allowing selectable serial numbers.

• Test equipment information automatically copied to calibration reports
• Fields can be used in TQExpress Custom Forms

Channel Configurations

• Allows multiple channel configurations selected on user managed names
• Automatically configures most loggers
• Select Input Type
• Select Chart Colour
• Select Units, Decimal Places
• User managed channel names

Running a Test

• Selection of Test Specification
• Entry of Job reference
• Entry of cycle number
• Selection of machine or facility being tested
• Custom entries are available
• Most application functions available while test is logging
• Or multiple TQSoft™ programs can be run from same folder, one logging a test, the other being used to create reports

Real Time Display

• Real time display window shows all values as soon as received from logger
• Includes time above temperature, lethality, correlation etc.
• Shows time elapsed, current stage, elapsed stage time

The Test Merge Feature

• Data from different kinds of logger can be merged into a new test record
• Specify how time differences are handled
• Specify a Test Specification to use for the new merged test record
• Select data from any number of tests and select specific channels to merge
• Auto selection feature on matching sensor locations

The Stages Window

• Stages window allows editing of file containing all possible stages, test specification stage list, or test record stage list
• Allows alteration of ‘interval’ setting for each stage
• Allows stages to be added from list of all possible stages
• Allows stages to be removed
• Allows user to manually enter the times of stages
• In real time mode allows the next stage in the test specification list to be manually added