TQSoft Validation Software | Isopharm

TQSoft Validation Software
21 CPR Part 11 Compliant

TQSoft is a leading validation software that works with most leading data acquisition and calibration equipment, and configurable for most thermal validation requirements.
Integrating with IPReport to make validation reporting quick and efficient.

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Security & 21CFR Part 11 Compliance

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

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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

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Test Specifications

Allow user to create unlimited Test Specification files
Allow new file to start with copy of existing one
Calculations tab allows setup of calculations based on each row of data
Lethality tab allows configuration of lethality calculations
Probe selection allowing location entry
Setup of stages for manual entry during the test
Setup of parameter specific to logger selected
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

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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

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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 colours according to value
If too many channels for one line, data is formatted to fit paper
All calculations can be shown
Electronic signature option

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The Chart

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

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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

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Chamber Records Database

User managed database of equipment or facilities tested with custom fields
Select machine for each test
Information automatically copied to test records
Filter records

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Test Equipment Database

Store all information on Test Equipment in database allowing selectable serial numbers.
Test equipment information automatically copied to calibration reports

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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

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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

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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

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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

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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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