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Q W 50819 Validation Documentation
Q W 50819 Validation Documentation
Busitech provides this validation so that customers can have confidence in Busitech
products and comply with their needs to use validated software.
Busitech programming code is proprietary to Busitech and not available for customer
review. All code is based on Visual Basic 6, a commercially released Microsoft
language and fully compatible with Microsoft Windows 10, 8 and 7.
Validation Process
The validation protocol (also known as a test plan) lays out the tests and success criteria
required by the validation process. Validation testing is typically organized into 3 steps:
Busitech only does IQ and OQ. PQ if necessary is the responsibility of the customer.
The validation report presents the test data relative to success criteria and documents any
discrepancies.
The validation process is repeated with each released version. Busitech maintains the
right to shorten the validation process or reapply the previous validation when
programming changes are known to have not changed specific areas of the program, as is
the case with some maintenance releases.
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Validation Protocol
Key risks
• Wrong file versions are installed.
• Necessary files are not successfully installed.
• Note: the customer may choose to not use the Busitech install program or the
customer may tamper with the files after installation. These changes are the
responsibility of the customer to validate.
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Validation Report
Installation Qualification (IQ)
Objectives and Success Criteria
All programs and files will be verified (relative to a master file list) as to their presence,
location, version number and compile date. A listing of Busitech installed programs and
files is shown below, showing the version number and compile dates.
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Existing files are overwritten only if the Date, Time and internal version numbers of the
files being installed are newer.
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Key risks
• Customer receives false signals…wrong or missing alarms, wrong colors or
wrong calculated control limits.
• Customer makes incorrect conclusions…inaccurate statistics, color zones or
calculated control limits.
• Features do not work properly or as intended.
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v6 - FFCFCFF N 99 99 PASS
v6 - FFCFCFF S-pop 456.346 456.346 PASS
v6 - FFCFCFF Max Value 2304.83 2304.83 PASS
v6 - FFCFCFF Avg 509.729 509.729 PASS
v6 - FFCFCFF Avg-Cur 462.569 462.569 PASS
v6 - FFCFCFF Min Value -860.08 -860.08 PASS
v6 - FFCFCFF OppmOSL 70707 70707 PASS
v6 - FFCFCFF CppmOSL 146400 146400 PASS
v6 - FFCFCFF Cr 1.83 1.83 PASS
v6 - FFCFCFF Tz 0.1 0.1 PASS
v6 - FFCFCFF Ppk 0.37 0.37 PASS
v6 - FFCFCFF Cpk 0.55 0.55 PASS
v6 - FFCFCFF Rule PASS
v6 - FFCFCFF Std Dev - Cur 575.277 575.277 PASS
v6 - FFCFCFF OnOSL 7 7 PASS
v6 - FFCFCFF USL - cur 1500 1500 PASS
v6 - FFCFCFF UCL - cur 999 999 PASS
v6 - FFCFCFF UWL - cur 1312.915 1312.915 PASS
v6 - FFCFCFF TGT - cur 450 450 PASS
v6 - FFCFCFF LWL - cur -412.915 -412.915 PASS
v6 - FFCFCFF LCL - cur 155 155 PASS
v6 - FFCFCFF LSL - cur 0 0 PASS
v6 - FFCFCFF %CV 89.527 89.527 PASS
v6 - FFCFCFF C%>TGT 55.17 55.17 PASS
v6 - FFCFCFF C%>UCL 14.23 14.23 PASS
v6 - FFCFCFF C%>USL 1.5 1.5 PASS
v6 - FFCFCFF C%>UWL PASS
v6 - FFCFCFF C%<LCL 21.77 21.77 PASS
v6 - FFCFCFF C%<LSL 13.14 13.14 PASS
v6 - FFCFCFF C%<LWL PASS
v6 - FFCFCFF C%<TGT 44.83 44.83 PASS
v6 - FFCFCFF C%OSL 14.64 14.64 PASS
v6 - FFCFCFF Cn>TGT 54.618 54.618 PASS
v6 - FFCFCFF Cn<UCL 14.088 14.088 PASS
v6 - FFCFCFF Cn>USL 1.485 1.485 PASS
v6 - FFCFCFF Cn>UWL PASS
v6 - FFCFCFF Cn<LCL 21.552 21.552 PASS
v6 - FFCFCFF Cn<LSL 13.009 13.009 PASS
v6 - FFCFCFF Cn<LWL PASS
v6 - FFCFCFF Cn<TGT 44.382 44.382 PASS
v6 - FFCFCFF CnOSL 14.494 14.494 PASS
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1. This version of QW5.0 runs under Asian versions of Windows. However, data
entered using the Asian double character set is not supported.
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QW 5.0 version 5.0.0.819 has been properly tested and checked as per the validation
protocol. All results match success criteria. All known issues have been identified and
communicated to Busitech technical resources to be resolved by the next release.
Validated by:
We indicate that we have reviewed the information and concur with the indicated
decision to consider QW 5.0 version 5.0.0.819 IQ/OQ validated.
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