12.7. Pass/Fail Report
Pass / Fail Report Overview
The Pass / Fail Criteria report can eliminate hours of manual or spreadsheet-based analysis,
by providing an automated report. This report analyzes Qualification raw data and details
whether the Qualification data successfully passed or failed to meet User defined criteria.
To better understand the functionality of the Pass / Fail Criteria report it is important to
understand the details of the following key elements:
What data from the Qualification raw data file is utilized to perform the Pass / Fail
•
analysis
How are the Pass / Fail Criteria calculations applied
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Qualification Raw Data File
The Qualification raw data file contains all the data captured from the Qualification Start time
to the Qualification End. The amount and content of the data is defined by the User in the
Setup report. The Setup defines the following:
•
Number and type of sensors included (i.e. temperature, pressure,)
Grouping of sensors (Distribution, Penetration, Shelf 1/Shelf 2 etc.)
•
•
Calculations (Statistical, Lethality, Saturation etc.)
Events triggering: Start and Stop of Qualification, Start and Stop of Exposure
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Any additional events based of defined process conditions
•
•
Sample / Storage Rate of data capture (timestamp interval)
Qualification time stamps and associated data are captured:
At the time Events occur (i.e., Qualification Start / Stop, Exposure Start / Stop, or
•
defined process events)
•
At User defined intervals based on configuration of the Sample/Storage rate.
Definition of Cycles
The Pass / Fail Criteria report allows the User to define a Cycle during the Qualification study
during which captured process data is analyzed. A cycle is a defined period during the
Qualification study. The ValProbe RT software allows the User in the Setup report to define
cycles (i.e., Qual Start to Qual End). Cycles can also be added or modified in the Reporting
Tool prior to generation of reports.
Figure 167: Pass/ Fail Criteria – Template Definition Screen
ValProbe RT User Manual
Chapter 12: Qualification Reports
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