Installation Qualification Protocol.

Installation Qualification Documentation.


You will find the step by step attached SOP delightfully simple and straightforward to use as it takes you through the process of customization. In this shop page you will find the Installation Qualification Protocol and combined SOP (SKU Number 850000) along with individual Test Scripts (SKU Numbers 850001 to 9) that are contained within it. Here these TSs are listed separately and can be purchased individually. SKU numbers 850010 onwards are test scripts that are required in addition to the basic ones for more specialized equipment.
   
Installation Qualification. SOP & Protocol.
$87.00  44.02
850000
The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.


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System Documentation Verification
$21.00  10.63
850001
Test sheets used in Installation Qualification Protocol to verify that the equipment documentation is as required in 21 CFR. Comes with standard IQ, but available seperately here.
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System Drawing Verification
$21.00  10.63
850002
Test sheets used in Installation Qualification Protocol to verify that the engineering drawings are as required in 21 CFR. Comes with standard IQ, but available seperately here.
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System Component Verification.
$21.00  10.63
850003
Test sheets used in Installation Qualification Protocol to verify that the system components are installed correctly and that the installation is documented as detailed in 21 CFR. Comes with standard IQ, but available seperately here.
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Sensor Calibration Verification.
$21.00  10.63
850004
Test sheets used in Installation Qualification Protocol to verify that all system sensors requirements as detailed in 21 CFR, are complied with, comes with standard IQ, but available seperately here.
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Electrical Conformance Verification (minor)
$21.00  10.63
850005
Test sheets used in Installation Qualification Protocol to verify that the system electrical installation conforms to good industry standards. Comes with standard IQ, but available seperately here.
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Verification of Lubricants
$21.00  10.63
850006
Test sheets used in Installation Qualification Protocol to verify that all CFR requirements concerning lubricants, construction and use, have been implemented and are being complied with. Comes with standard IQ, but available seperately here.
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Critical Area Material of Construction Verification.
$21.00  10.63
850007
Test sheets used in Installation Qualification Protocol to verify that all system product contact parts are manudfactured from a suitable material. Comes with standard IQ, but available seperately here.
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System Future Maintenance Verification.
$21.00  10.63
850008
Test sheets used in Installation Qualification Protocol to verify that post qualifiction maintenance of system is adequate and complies with 21 CFR requirements. Comes with standard IQ, but available seperately here.
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Security of Back-up Software Verification.
$21.00  10.63
850009
Test sheet used in the operational qualification protocol to verify whether any software in use with this equipment has a back up made and whether the storage and security of the software conform to the requirements as given in 21 CFRs. This document is included in the standard OQ, but available separately here.
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Analog Address Verification.
$22.00  11.13
850010
Analog Loop address verification. This confirms and documents that that the computer input specified in the system specification of the loop is correct. A mandatory part of system validation. This document is included in the standard IQ, but available separately here.
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Input Output Address Verification.
$21.00  10.63
850011
Input output address verification is mandatory, and is executed to document and verify that the computer input output address configurations is in accordance with the drawing specifications. Only available here as a paste in addendum to the Installation Qualification.
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Change and Consumable Parts Verification.
$22.00  11.13
850012
This test verifies that the change and consumable parts that are required to operate and maintain this equipment in its validated status are available to the operators. It is standard in the basic Installation Qualification, but available here as a separate download.
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HEPA Filter & Seal Integrity Test.
$22.00  11.13
850013
This test is used to verify that there are no leaks of none filtered air through the HEPA filter seals and that air entering through the HEPA filters is being filtered to the correct specification. It is included in the HVAC Installation Qualification, and is available here for separate download and purchase.
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Process Valves Records Of Tests & Inspections
$36.00  18.22
850014
Process Valves Records of Tests and Inspection, consists of mandatory tests and inspections that are requires to be executed and documented in the verification that all the listed valves conform to their respective drawing specification. Only available here as a paste in addendum to the Installation Qualification.
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Analog Loop Tests
$21.00  10.63
850015
Analog Loop testing. This confirms and documents the integrity of the entire loop, and is a mandatory part of validation of system. Only available here as a paste in addendum to the Installation Qualification.
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Pipe Work Record Tests & Inspections.
$36.00  18.22
850016
Test sheets used in Installation Qualification Protocol to verify that all system pipe-work is installed in accordance with the drawing and specification. Not included in standard IQ. Only available here as a paste in addendum to the Installation Qualification.
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Verification of Vessel Installation.
$36.00  18.22
850017
Verification of Vessel Installation, covers all the installation details that must be verified to confirm that the vessel is installed in accordance with the drawing specification.Only available here as a paste in addendum to the Installation Qualification.
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