Decagon Devices AquaLab 4TE, AquaLab 4TE DUO, AquaLab 4TEV, AquaLab 4TEV DUO Installation Qualification/operational Qualification Protocols And Instructions
Installation Qualification/Operational Qualification
Protocols and Instructions
AquaLab 4TE, 4TEV
4TE DUO and 4TEV DUO
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Table of Contents
Section 1
Section 2
Section 2.1
Section 2.2
Section 2.3
Section 2.4
Section 2.5
Section 3
Section 3.1
Section 3.2
Section 3.2.1
Section 3.2.2
Appendix 1
Appendix 2
Introduction
Installation Qualification (IQ)
Equipment Identification
Receiving and Unpacking
Visual Inspection
Environmental Conditions
Power Up Test
Operational Qualification (OQ)
Hardware testing
System information
Sensor Verification
Equipment Familiarization
Training Record
Deficiencies and Corrective Actions
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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 representative then signs the approved form.
Installation Qualification (IQ)
Installation qualification is documented proof that the instrument was received as designed and specified by the manufacturer, that it is properly installed in the selected environment, and that this environment 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
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and frequency are solely under responsibility of the user. Performance validation should be designed to meet
the specifications and accuracy for a given application.
Equipment familiarization and operator training records
All equipment users are to be instructed in basic operation, functionality, instrument parameters, as well
as on basic hardware features of the installed system including routine maintenance and cleaning procedures. Please contact Decagon Devices to learn about available training and seminars.
Authorized support specialists perform the qualification services offered by Decagon Devices.
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Section 2 – Installation Qualification (IQ)
Initial Qualification and Requalification
The IQ protocols described below are dedicated to initial qualification and/or to requalification. Installation Qualification tests should be performed, 1) when the system is installed, 2) when the system is
moved to a new location, 3) prior to running OQ tests.
This section describes the procedure for receiving, unpacking, and installing a Series 4 AquaLab
Water Activity instrument.
The purchased AquaLab Water Activity instrument undergoing qualification is located at:
Company Name:
Department:
Address:
City: State:
Country:
Zip code/Postal Code:
Phone Number:
2.1 Equipment identification
Fill out this section after unpacking the AquaLab instrument and corresponding accessories.
4 4TE 4TEV 4TE DUO 4TEV DUO
Manufacturer: DECAGON DEVICES
Model Number:
Serial Number:
Decagon Devices Authorized Representative
Name:
Date:
Signature:
Initials:
2.2 Receiving and Unpacking
Verify that the external packaging was not damaged during shipment in a way that the internal package
content might be damaged.
External package condition Satisfactory Not Satisfactory
Remarks: N/A
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