SQT- Qualification Testing process
Qualification testing process starts with a detailed analysis of
desired needs and required outcomes. This leads to development of a detailed
User Requirement Specification, URS. The URS ultimately drives what needs to be
tested. For life sciences GAMP-5 validation is needed.
Factory Acceptance Tests/Site Acceptance Tests (FAT/SAT)
FAT and SAT testing is conducted to ensure that the automation
integration functions as intended before it is put into production. Checklistapproach is generally used for FAT/SAT. In pharmaceutical projects and anyother project requiring formal process qualification testing, the FAT/SAT is completedprior to the commencement of qualification activities. For FAT tests, inputsare simulated in a virtual environment to test the automation controllers and
software without having to connect to the production equipment. SAT on the
other hand is conducted onsite. For efficiency, SAT test procedures need to be
written in a detailed manner that allows them to be leveraged so they can be
reused and accepted as part of the validation OQ.
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Typically, SAT begins with a complete I/O check: all external inputs
are applied and corresponding outputs measured to ensure that the expected
outputs are occurring. Next, a physical device test is performed, in which
power is supplied to each motor, pump, valve etc. to ensure that each is
connected properly and is functional. Then the devices in the system are
manually exercised using the HMIs. All automated sequences are tested for
functionality. For fast paced projects it needs to be seen that the device,
wiring, PLC, HMI are all communicating and working together or not.
Validation
A validation master plan (VMP) is essential for a project. The VMP
is, in short, a written procedure to describe the process of achieving and
maintaining a qualified piece of software, equipment or a facility. It
describes what will be tested, how the tests will be conducted, the
documentation that will be required, and who must be involved during
validation.

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