P R O D U C T
Installation Qualification and
w w w. p e r k i n e l m e r. c o m / i n s t r u m e n t s
N O T E
Be confident your results selected key activities performed Key Capabilities
will be accurate and and verified during installation,
Our IQ/OQ program produces
compliant everyday. before the instrument is put into
the thorough audit trail needed
service for actual analysis. The to meet internal and external
It is not enough that your labs IQ/OQ documentation is specifically validation requirements
instruments perform to manufac- designed to your instrument
Documented tests confirm proper
turers standards. More importantly, including your company name,
installation and operation
they need to meet the regulatory address, instrument serial number,
requirements of your lab everyday. purchase order number and an Log book for recording instrument
PerkinElmers team of service individualized protocol number. history ensures your instrument
follows good GLP and GMP guidelines
experts understand the increasing This is more than a simple instru-
need for validation and regulatory ment performance verification More factory-trained service people
compliance and has designed a our IQ/OQ program produces the than anyone else in the industry,
available globally
complete Installation and Operational thorough audit trail of system
Qualification (IQ/OQ) program performance you need to meet
including an extensive Log Book validation requirements imposed
for complete instrument history. by internal and external regulatory
This complete program provides groups giving you the confidence
a permanent record identifying in your instrument everyday.
Ensure youre ready to go Compare equipment as received Install hardware including all
right from the start with purchase order including soft- tubing, columns, cables for power,
ware, accessories, spare parts, and data flow and instrument control
Installation Qualification (IQ) provides
documentation such as tutorials,
formal checks and documentation Install or confirm factory installation of
manuals and operating procedures
to confirm that the instrument and its software on the computer following
components have been supplied as Check equipment for any damage the installation instructions
ordered and properly installed in during shipping
Configure peripherals, e.g., printers
your lab environment (Figure 1).
Check that the documentation and equipment modules
Upon delivery, the shipment will be
supplied is of the correct issue
visually inspected and reviewed for Document equipment tutorials,
completeness followed by installation of Establish that the laboratory manuals and operating procedures
all hardware, software and peripherals. environmental requirements are
Once completely installed, the system Perform installation functionality
appropriate for the instrument (power,
will be turned on to confirm all check and prepare installation report
bench, lighting, accessibility etc.)
modules and systems work correctly. Activate utilities and pre-condition
Finally, all information determined is Review all hazards and safety
instrument (e.g. warm-up, leak-test,
then documented within the protocol. precautions, including materials
flow controls etc.)
that may come in contact with
For the Installation Qualification the instrument Check that the response to the
PerkinElmers Customer Support initial application of power is as
Engineers will: expected and record deviations
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