Operational Qualification Protocol.

Operational 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 of your Operational Qualification Protocol. In this shop page you will find the Operation Qualification Protocol and combined SOP (SKU Number 860000) along with individual Test Scripts (SKU Numbers 860001 to 9) that are contained within it. Here, these TS’s are listed separately, and can be purchased individually. SKU numbers 860010 onwards are test scripts that are required in addition to the basic ones, for more specialized equipment.
   
Operational Qualification, SOP & Protocol.
$87.00  £44.02
860000
This Operational Qualification SOP and Protocol, can be simply and quickly converted (using find replace techiques) into your own document. Following the attached SOP can further convert it into your completely bespoke Operational Qualification Protocol, speedily raised and ready to issue for approval signatures, prior to execution.
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System Documentation (SOP) Verification.
$21.00  £10.63
860001
Test sheet used in operational qualification to verify that all the SOP requirements in CFR 21 for this type of equipment are in place and are approved company documents. Included in the standard OQ, but available separately here.
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Operating System Software Verification.
$21.00  £10.63
860002
Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Included in standard OQ, but available seperately here.
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Test Equipment Calibration Verification.
$21.00  £10.63
860003
Test sheet used in the operational qualification protocol to document and verify that all test equipment and sensors used in the execution of the operation qualification are calibrated, and have traceable calibration standards. This document is included in the standard OQ, but available separately here.
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Power failure Test.
$21.00  £10.63
860004
Test sheet used in the operational qualification protocol to document and verify that when the equipment is subjected to an unintentional loss of electric supply it will fail and be reinstated in a manner save to the product and operating personnel. This document is included in the standard OQ, but available separately here.
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Radio Frequency InterferenceVerification.
$21.00  £10.63
860005
Test sheet used in the operational qualification protocol to document and verify that when the operation of equipment will not be adversely affected by the use, near by, of radio emitting devices. This document is included in the standard OQ, but available separately here.
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Application Software Identification Verification.
$21.00  £10.63
860006
Test sheet used in the operational qualification protocol to document and record the issue level, date of issue and title of the application software that the equipment under qualification has installed during execution of this operational qualification. This document is included in the standard OQ, but available separately here.
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21 CFR Part 11 Eligibility Verification
$35.00  £17.71
860007
Test sheet used in the operational qualification protocol to document and record whether the equipment produces data that necessitates compliance with 21 CFR Part 11. This document is included in the standard OQ, but available separately here.
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Equipment Function Test.
$21.00  £10.63
860008
Test sheets used in the operational qualification protocol to review and comment on a completed function test schedule, which has been used to verify the functionality of the equipment under qualification. This document is included in the standard OQ, but available separately here.
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HEPA Filter Clean PD Correction.
$32.00  £16.19
860009
The manufacturers dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download.
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Software Quality Verification.
$21.00  £10.63
860010
Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Not Included in standard OQ, but available seperately here.
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Quality Water Alarm Test
$22.00  £11.13
860011
When water quality falls to a preset limit during service, this conductivity sensor will automatically go into an alarm condition. It is required in this protocol to demonstrate that this operates and to record the level it activates and deactivates at. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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Zone/Room Air Change Rates
$28.00  £14.17
860012
It is required in this test script to demonstrate that the air rate of change in the room / area /zone conforms with the user requirement specification. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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Verification of Password Controlled Access.
$22.00  £11.13
860013
It is required to verify in this test script that access to the equipment is controlled by the use of passwords, and that the passwords are graded to allow access only for their authorized job functions. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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21 CFR Part 11, Verification.
$36.00  £18.22
860014
This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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De-ionizer Unit Regeneration Test
$22.00  £11.13
860017
Quality of the de-ionized water is continually monitored by a conductivity meter. When water quality falls to a preset limit during service, the conductivity controller in the de-ionizer unit automatically shuts the input solenoid valve isolating the water supply. This indicates that the resins are approaching exhaustion and require regeneration. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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Security of Back-up Software
$22.00  £11.13
860018
It is mandatory that where software has to be validated, there is a certified true copy, of that software stored in conditions laid down by cGMP's. This test script verifies that these conditions are being met. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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Water Velocity Test.
$22.00  £11.13
860019
Water velocity through the distribution loop should be maintained within set parameters. Correct speed above ensures adequate scavenging of dead legs takes place. To high a speed induces excess turbulence which inhibits scavenging. It is required in this protocol to confirm that the water velocity is correct. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.
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Safety/Health/Environmental Assessments
$22.00  £11.13
860020
There are several Health, Safety and Environmental assessments that must be carried before an item of equipment is put into service. This test script ensures that they are all in place and available for review. This document is not included in the standard operational qualification, but is a available here as a direct download.
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