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HVAC.

Validation Master Plan (Issue 7)
$115.00
10000001
This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Validation Risk Assessment assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

Document Statistics

 Protocols = 1

Pages = 47 

Paragraphs = 945       

Lines = 1801 

Words =  9922 

 Characters = 66311

 Graphics = 15

 Size = 789 KB


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Validation Documentation Matrix (Issue 6.)
$29.00
10000002
This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.
Please remember that this document is an Excel document, so when your download link arrives you must use Excel to open it


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User Requirements Specification (Issue 7.)
$115.00
10000010
The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

Document Statistics

 Protocols = 1

Pages = 27 

Paragraphs = 481         

Lines = 1374 

Words =  2563 

 Characters = 18021

 Graphics = 14

 Size = 302 KB


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Facility_Combined_IQ-OQ_Issue-2
$125.00
10000501

This Combined IQ OQ protocol is a really easy and attractive document to use.  It is prefaced by a 10 page SOP, which enables you to follow the SOP instruction and progressively (page by page) convert this fully detailed template into a superb IQ/OQ protocol.

 

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line.  All standard verifications are already included in the protocol format with many more testscripts that can be edited in or out to tailor your IQ/OQ protocol exactly to your regulatory requirements.

This new combined IQ OQ protocol brings a refreshingly simple and attractive approach for the industry professional to raise professional quality validation protocols in a most cost effective way.


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HVAC System DQ (Issue 3.)
$89.00
10001005
This HVAC Design Qualification along with the attached Standard Operating Procedure, will chapter by chapter take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is a superbly easy document to use and will ensure that you�re DQ�s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

Document Statistics

 Protocols = 1

Pages = 29 

Paragraphs = 634        

Lines = 1961 

Words =  3142 

 Characters = 19475

 Graphics = 19

 Size = 316 KB


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HVAC System IQ (Issue 6.)
$115.00
10001010
This Heating Ventilation and Air Conditioning, Installation Qualification comprises of an SOP and a very detailed IQ template. It does most of the work for you and makes it so easy for you to raise a quality IQ. The final product is a professional and comprehensive Heating Ventilation and Air Conditioning 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, or a complete suite in one day.

Document Statistics

 Protocols = 1

Pages = 51 

Paragraphs = 1030     

Lines = 3240 

Words =  6006 

 Characters = 38541

 Graphics = 39

 Size = 581KB


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HVAC System OQ (Issue 6.)
$115.00
10001020
This Operational Qualification SOP and Protocol, can be simply and quickly converted (using find replace techniques) into your own company bespoke document. Now you can purchase these documents individually or as a suite (VP to PQ). Purchasing as a suite ensures that your validation is properly structured, and will pass regulatory review.

Document Statistics

 Protocols = 1

Pages = 40 

Paragraphs = 664      

Lines = 2291 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 397 KB


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HVAC System PQ (Issue 4.)
$89.00
10001030
This superb HVAC Performance Qualification is the last in the chain of qualifying tests that HVAC systems are subjected to, before being considered qualified. However environmental qualification is required to confirm air quality and containment.

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Package HVAC Validation Level-1. (Issue 5)
$499.00
10001040
You have a major component change or major modification to validate; This Validation Package contains one of each of these documents:
VP, URS, DQ IQ, OQ, PQ.
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Package HVAC Validation Level-2, (Issue 3)
$675.00
10001050
This package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. This Validation Package contains one of each of these documents:
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ.
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Package Building Management System (BMS) Validation. (Issue 2)
$675.00
10001120
This Building Management System (BMS) package of templates simplifies your task of authoring all the required documents to qualify a BMS system. With these interactive fully detailed documents the hard work is practically all completed for you. The final product is a professional and comprehensive Building Management System (BMS) suite of documents, already for execution. This Building Management System validation package contains the full range of interactive validation documents and protocols:

VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
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Verification of Lubricants (Issue 2.)
$16.00
11000162
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 separately here.


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Analog Address Verification (Issue 3.)
$16.00
11000165
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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Analog Loop Tests (Issue 3.)
$16.00
11000166
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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Application Software Identification Verification (Issue 2.)
$16.00
11000167
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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System Drawing Verification (Issue 2.)
$16.00
11000172
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 separately here.


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Electrical Conformance Verification (minor) (Issue 3.)
$16.00
11000173
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 separately here.


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Equipment Function Test (Issue 1.)
$16.00
11000174
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 & Seal Integrity Test (Issue 5.)
$16.00
11000175
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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Input Output Address Verification (Issue 3.)
$16.00
11000176
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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Power failure Test (Issue 3.)
$16.00
11000180
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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Process Valves Records Of Tests & Inspections (Issue 6.)
$16.00
11000182
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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Operating System Software Verification (Issue 3.)
$16.00
11000183
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 separately here.
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HEPA Filter Clean PD Correction (Issue 3.)
$26.00
11000184
In a non compensating HEPA flow regime a dirty filter will progressively reduce the room airflow. This can resultant in insufficient air flow to protect staff and or the product, it can be dangerous for both. If you started with an actual flow that was only 40% of the rated flow, the filter would be seriously blocked before you reached the un-corrected dirty filter change PD. This is why regulators will ask for the filter clean DP justification calculations.

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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Radio Frequency InterferenceVerification (Issue 5.)
$16.00
11000185
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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Room Air Flow Regime (Issue 3.)
$26.00
11000186
The inter-room and room air flow is design to safeguard the product and often the staff. It is required in this test script to verify that the inter room and or room air flow are as specified in the design specification (drawing). This test script is not in the standard operational qualification, but is available here for direct download.


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Safety/Health/Environmental Assessments (Issue 2.)
$16.00
11000187
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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Security of Back-up Software (Issue 3.)
$16.00
11000188
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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Sensor Calibration Verification (Issue 3.)
$16.00
11000189
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 separately here.


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System Component Verification (Issue 2.)
$16.00
11000191
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 separately here.


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System Documentation (SOP) Verification (Issue 3.)
$16.00
11000192
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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System Documentation Verification (Issue 3.)
$16.00
11000193
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 separately here.


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System Future Maintenance Verification (Issue 3.)
$16.00
11000194
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 separately here.


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Test Equipment Calibration Verification (Issue 6.)
$16.00
11000195
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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Verification of Password Controlled Access (Issue 2.)
$16.00
11000197
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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Airborne Particle Verification.
$26.00
11000198
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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Microbial Level Verification.
$26.00
11000199
It is required in this test script to verify that the air borne CFU count rate 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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Zone/Room Air Change Rates (Issue 3.)
$16.00
11000200
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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