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During a kick off meeting, validation approaches and documentation specifications are reviewed and mutually agreed upon.
The design of the machine, its specifications and project risks are scrutinized and evaluated in a design review and then the framework determin-ing the conditions of the IQ/OQ testing is laid out. Subsequently, specially trained technical authors edit the detailed test protocols and documents for each project in close cooperation with the customer.
FS HDS SDS
During IQ, we document that the machine was installed according to what is specified by the
DQ requirements and that all components, which are relevant for the operation of the machine are present and meet their intended specifications. Typical areas for IQ testing are:
components critical to the process
controls systems and loops
change parts
PC and PLC hardware
utility connections
loop tests
Usually this IQ is executed at the customer´s
site, a modified process which executes IQ at Seidenader is optionally available.
After installation and site acceptance testing, the operational qualification has to prove in detailed tests, that all critical operation parameters are within the defined ranges. All testing is protocolled and described in detail.
Safety functions
Machine functions
Operator interface
Validation / Documentation
DQ / IQ / OQ
Spare Parts / Service
Customer Support
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Verify installed components
Checking of critical parameters