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Section 1 – Introduction
This Qualification protocol is solely intended to be used with new or relocated AquaLab Water Activity
instruments. It is written to assist the end-user in validation of predetermined specifications.
The use of this document does not replace the need for the AquaLab Series 4 User's Manual. Information
within the User's Manual is required to complete this IQ/OQ Protocol. If the manual has been misplaced,
copies can be obtained from the manufacturer or downloaded from their website, www.aqualab.com.
Qualification of instrumentation is a formal process of documenting that an instrument is fit for its intended
use and that it is kept maintained and calibrated.
Responsibilities
The instrument qualification carried out onsite is the sole responsibility of the instrument owner/user.
However, Decagon Devices supports their customers in performing the qualification by providing the
instrument qualification dedicated documentation and offering a qualification service. In this regard, the
following responsibilities are defined:
Performance of Qualification
Execution of the instrument qualification and entire qualification of the installed system covered in
this document is performed by a Decagon Devices trained and authorized service personnel
when ordered from a customer.
Review and final qualification approval
Final approval for the qualification has to be completed after review of the qualification documentation
filled out during performance of the qualification procedures (IQ/OQ protocols). The customer repre-
sentative then signs the approved form.
Installation Qualification (IQ)
Installation qualification is documented proof that the instrument was received as designed and speci-
fied by the manufacturer, that it is properly installed in the selected environment, and that this environ-
ment is suitable for the operation and use of the instrument. The IQ section therefore describes and
documents the instrument installation in the pre-determined environment. Further, the IQ verifies and
ensures that all ordered parts and documentation are in place and that all supplied items are in working
order and condition.
Operational Qualification (OQ)
The operational qualification serves as proof that the equipment operates as designed and intended,
as well as fulfills acceptance criteria defined and stated in the Operational Qualification documentation.
These criteria are defined and are based on the equipment technical specifications of the manufacturer.
Performance Qualification (PQ)
Performance qualification is documented proof that an instrument consistently performs according to the
specifications appropriate for its routine use. Monitoring of equipment during routine operation is essential
for ensuring that the ongoing performance is within specifications. The performance qualification, execution
Decagon Devices, Inc
June 28, 2016 11:24 AM
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