Original PDF File
15 December 18
IQ/OQ Leaflet UK
IQ/OQ Leaflet UK, Installation and Operation Qualification, Peak Protected
Your local gas generation partner
a time that
Providing certified assurance for your
Peak Scientific gas generators define the industry benchmark
for reliable, consistent and convenient gas supply for analytical
instruments in laboratories the world over.
However, sometimes it is not enough that your laboratory gas
generator performs to the manufacturers’ standards; it may also
need to meet the strict regulatory requirements outlined by the
Food and Drug Administration (FDA) or equivalent EU regulatory
Here at Peak Scientific, we understand the increasing need for
validation and regulatory compliance. With customer service and
support at the very core of everything we do, we have developed
a comprehensive Installation and Operational Qualification
certification service for customers who require additional certified
assurance for their analytical applications.
The Peak Scientific IQ/OQ certification service is tailored to
your specific gas generator. It delivers a cost effective & efficient
solution to help you achieve and maintain regulatory compliance.
In addition to our highly trained and dedicated Service Engineer
completing the Installation and Operational validation, we will
also provide full certification to document this process, ensuring
accurate proof of compliance.
What is IQ?
IQ is the detailed check of the equipment installation covering its component
parts and its location on-site. The main aim of IQ is to provide documented
confirmation that the gas generator is physically fit for purpose, comes with
all relevant documentation and its operating environment meets manufacturer
Once your dedicated Service Engineer has completed the review of the
installation review and confirmed the generator is configured correctly, you
can be assured that your equipment is set up correctly.
YOUR CERTIFIED IQ/OQ PEAK SCIENTIFIC ENGINEER WILL:
• Compare the equipment received with the purchase order including:
accessories, firmware and relevant documentation such as operation manuals
• Check the gas generator for possible damage during the delivery process
• Assess the environment that the gas generator will be
placed in, making sure there is adequate ventilation
• Review hazard and safety precautions for the area of use, including
materials that may come into contact with the generator and/or personnel
• Perform an installation functionality check and produce an installation report
• Record all relevant activities and actions and sign all relevant documentation
• Complete a certificate of conformity
NB: IQ does not include the actual installation of the generator. Physical installation can
be requested at an additional cost.
What is OQ?
D E SCR I P TIO N
Once the gas generator installation has been validated, your Peak Service
Engineer can complete an Operational Qualification to verify that the
equipment functions in accordance with manufacturer specifications. The
Service Engineer will also confirm that the gas generator satisfies the requirements of your instrument based on its agreed metrics.
YOUR CERTIFIED IQ/OQ PEAK SERVICE ENGINEER WILL:
• Ensure the gas generator is functioning to the acceptable standard
by testing the generator’s specification parameters and ranges
against the technical specifications of the equipment
• Perform basic training with the generator to ensure your team
are able to use it as intended, safely and with confidence
• On completion of the OQ, all operational tests will be documented, the
results validated and all relevant certificates completed & signed
WHEN SHOULD I CARRY OUT AN OQ?
• When the generator is installed or relocated
• On a periodic basis in accordance with your standard operating procedures
• After a major repair
• Before a previously installed system is used in a regulated test environment
for the first time
IQ/OQ How does it work?
Peak Scientific’s IQ/OQ is tailored to your
You request IQ/OQ
sent to you
Your generator is
Peak Service Engineer
completes IQ/OQ on-site
Were there any irregularities found
during IQ/OQ process?
Peak Field Service Engineer will
resolve the issue on-site
IQ/OQ validation documentation
completed and certificate given
for customer’s company records
*If you need a Peak Field Service Engineer to install your generator, this can be requested at an additional cost.
Why Peak for IQ/OQ?
Gas generator experts
Peak’s Field Service Engineers are best positioned to provide the IQ/OQ
certification your industry requires, because they have been rigorously trained
on Peak gas generator systems and work with them day in, day out.
YOUR CERTIFIED IQ/OQ PEAK SERVICE ENGINEER IS:
• Trained in-house by a team with decades of gas generator systems
• Re-tested annually to ensure they continue to meet Peak’s high standards
• Local to you, with dedicated engineers located throughout the world
• Supported by specialists across many fields from gas chromatography
users to worldwide logistics
Local Peak Office
Direct Peak Field Service Engineer Location
No matter your laboratory size or specific analytical application, Peak Scientific can assist you in improving and verifying
your laboratory’s performance. With a local direct presence in over 20 countries across every continent around the
world, Peak Scientific has highly trained and fully certified Field Service Engineers on hand to assist you soon after your
instrument delivery, minimizing any delay or downtime and maximizing your laboratory’s productivity.
To discuss our IQ/OQ services please speak to your local Peak Representative or for further information please contact our
dedicated service team at: email@example.com.
Peak Scientific HQ
Tel: +44 141 812 8100
Fax: +44 141 812 8200
For a full list of our worldwide
office locations, please visit:
[Peak Protected]™ and all other trademarks relating to Peak Scientific products mentioned herein belong to Peak Scientific Instruments Ltd.
The trademarks and names of other companies and/or products mentioned herein are the property of their respective owners.
Copyright Peak Scientific - IQ OQ Leaflet - Rev6 PN 3300129 - 08/05/2017