Last Modified: Thursday, September 19, 2019

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

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