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For more information, please contact:
6 Warner Rd.
Warner, NH 03278 (603) 456-2011
What IQ/OQ/PQ Services Are - and Why You Need Them
Whether you are running tests in a laboratory, gathering data in the field, or operating medical
devices on behalf of patients, you must be able to trust that your equipment is performing well
and that the data you are receiving is accurate.
Equipment validation – often referred to as Installation Qualification (IQ), Operational Qualification (OQ), and
Performance Qualification (PQ) – provides you with a way of assessing how well your equipment is functioning.
IQ/OQ/PQ may also be required by association, state, or federal guidelines depending upon your industry and the
regulatory agencies that oversee your work.
Installation Qualification (IQ)
IQ happens when you purchase or
upgrade your equipment and
software. IQ starts when you receive
the product and ends with the
knowledge that correct information
can pass between the equipment
and the workstation where the
software has been installed. For
example, if you purchased a wireless
temperature monitoring system,
you'd verify that you received
everything in good condition, had full
supporting documentation, installed
the temperature recorder, and that
the data logging software was
sending information that was being
received by your workstation.
Operational Qualification (OQ)
OQ can only occur after a
successful installation. During
this phase, you'd ensure that
your data loggers are recording
and sending accurate
information to your workstation.
You would also ensure that
proper procedures are
established and followed for the
main functions of the new
system and that handling and
maintenance information was
available. OQ would be
completed when you verify that
the data logger system is
operational.
Performance Qualification
(PQ)
PQ takes place as your new
system is used. You may be
given recommendations to
enhance the long-term accuracy
of your data logger system,
along with information about
periodic maintenance needs.
The system will likely require
periodic calibration as well. PQ
ensures that your data logging
software and equipment perform
acceptably – or even
exceptionally well – over time.
Why IQ/OQ/PQ Matters To You
These structured forms of verification and validation can be essential for many reasons. If your company reports to
any regulatory agencies, the process leaves you with necessary documentation to prove to auditors, investigators,
and the like that you take their regulations seriously and that the information and services you provide conform to
industry standards. Within your own organization, it gives insight into processes and procedures as well as employee
performance, which can lead to improvements in efficiency and innovation. It also gives you an effective means of
evaluating the equipment and software provided by your vendor, which will be invaluable when the time comes for
investing in new systems or upgrading your existing ones.
MadgeTech offers Secure Data Logging Software including IQ/OQ/PQ protocols to aid in compliance with 21 CFR
Part 11. On-site IQ/OQ/PQ services are also available for protocol generation, training and validation assistance.
With the help of expert MadgeTech employees, your company will save time and money and minimize staff disruption
while implementing IQ/OQ/PQ protocols for your MadgeTech data logger system. After working with MadgeTech,
you'll receive a comprehensive final report that documents all of the testing performed, the results that were obtained,
and recommendations for testing, future performance qualification, and ongoing maintenance that is customized to
your site.