User's Manual

Chapter 11: Qualification Reports
Kaye ValProbe RT User Manual 113
For Time at/below Process Temperature per Sensor, the system accumulates time for each
sample interval A1/A2, A2/A3...A5/B1) only if both, the data points at the beginning and end of
the sample interval are beyond (above/at/below) the defined condition.
If for example, a data point (A1) has reached the given criterion threshold, the system checks
if the next data point (A2) has reached the given criterion threshold as well. In that case, the
interval between the data points are counted toward the accumulated value.
Pass / Fail Criteria – Template Definition
The Pass / Fail Criteria template screen allows the user to create and save new templates or to
select an existing template for generation of a report. The existing template selection can be limited
to similar asset types or selected from all available asset types. For each template, the user can
define the selected cycle, the process temperature, and the selected criteria they want applied and
analyzed.
Figure 123: Define / Select Template Screen
The template definition screen offers a total of up to 16 different criteria to select from. The
criteria are based on years of experience, as well as specific regulatory requirements from a
host of different processes (i.e. Sterilizers – EN285).
Users can create and save an unlimited number of Pass/ Fail Criteria templates which can
then be selected and run to analyze any Qualification study.
The User Management section of the software allows the Administrator to define access and
privileges associated with the creation and modification of the templates.
Once the template has been selected or defined the user can select which Groups to include
in the report and used for the analysis. Each Group of sensors has their own analysis and
report pages.