User's Manual

Chapter 11: Qualification Reports
Kaye ValProbe RT User Manual 100
Qualification Reports
11.1. Reports Overview
The Kaye ValProbe RT software includes a comprehensive reporting utility that allows you to
generate Setup, Calibration, Qualification, and Calibration Verification reports to document the
specifics of your validation study. These reports give the flexibility to perform a thorough
analysis of process performance, while meeting regulatory guidelines for 21 CFR Part 11 and
Data Integrity guidelines.
Available reports include:
o Setup reports
o Detailed reports
o Summary reports
o Graph reports
o Audit Trail
o CSV Export (Excel)
o Pass / Fail Criteria reports
All reports are created from raw encrypted study files generated during the validation
processes. Raw file content cannot be modified or tampered with.
All qualification reports are arranged in groups. A user can select which groups and
calculations are included in each report. Individual groups can have specific headers.
Reports are created in .pdf format. They are stored with the appropriate asset under Reports
for future access and analysis.
The following sections provide an overview of each report as well as the methods to generate
them.