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Cold Chain Utilities.

Validation Risk Assessment (Issue11.)
$125.00
10000014
The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorising and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

Document Statistics

 Protocols = 1

Pages = 18 

Paragraphs = 344         

Lines = 810 

Words =  341 

 Characters = 20084

 Graphics = 10

 Size = 179 KB


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Cold Chain Validation Package level-1
$587.00
10000396

The contents of this package is the six documents that make up the advertised document package.
THERE ARE NO DATA LOGGERS IN THIS PURCHASE.
The Validation Plan (VP) must detail what you are going to do, who is going to do it, when, how and where they are going to do it. The User Requirements Specification (URS) must document exactly what the end user wants this equipment to do. The Design Qualification (DQ) will verify the design. Validation Risk Assessment (VRA) will define the depth of validation required and document the justification; a requirement mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. Each of these documents is mandated by cGMP's. There are no compliant short cuts.
VP, URS, DQ, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents, but no data loggers.


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Cold Chain Validation Package Level-2
$1,699.00
10000397

This package is suitable for rooms or cabinets up to 10 cubic meters and arrives complete with all the validation documentation you require to validate the temperature condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP), The equally well detailed User Requirement Specification (URS), the Validation Risk Assessment (VRA). The Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are ten, temperature easy to use data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
10 off Temperature Data Loggers (Capacity 18k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 1 to 2 cubic meters. Compatible with a 10 foot Reefer or container

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Cold Chain Validation Package Level-3
$2,654.00
10000398

This package is suitable for rooms or cabinets up to 50 cubic meters and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, room or a cabinet. Documentation includes our interactive and detailed Validation Plan (VP), the equally well detailed User Requirements Specification (URS), the Validation Risk Assessment (VRA) and the Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are twenty temperature data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select.
Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
20 off Temperature Data Loggers (Capacity 17k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 5 to 25 cubic meters. Compatible with a 20 foot Reefer or container


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Cold Chain Validation Package Level-4
$4,064.00
10000399

The contents of this package includes quantity 30 off, single channel data loggers. Simple and robust to use; their use renders the whole validation task - much simpler. There needs to be a User Requirements Specification (URS) that will document exactly what the end user wants. The Design Qualification DQ will verify that the design is compliant with URS. This needs a Validation Risk Assessment (VRA) to define the depth of validation required and to document this decision; as is mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). All these documents are fully detailed and are designed to be simple and expedient for the end-user to follow.
This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. VP, URS, DQ, VRA, IQ, OQ, PQ. - This package consists of one of each of these documents. Plus 30 off single channel temperature data loggers. This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 20 to 60 cubic meters. Compatible with a 40 foot Reefer or container

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Climatic Controlled Zone IQ (Issue 3)
$115.00
10000400
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 for your temperature controlled cabinet or room. 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.

Document Statistics

 Protocols = 1

Pages = 51 

Paragraphs = 1030     

Lines = 3240 

Words =  6006 

 Characters = 38541

 Graphics = 39

 Size = 581KB


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Climatic Controlled Zone OQ (Issue 12).
$115.00
10000404
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 template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol for your temperature controlled cabinet or room. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.

Document Statistics

 Protocols = 1

Pages = 40 

Paragraphs = 664      

Lines = 2291 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 397 KB


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Combined Climate Controlled Zone IQ/OQ/PQ (Issue 10)
$159.00
10000404
This combination protocol has been produced in response to several hundred reader suggestions we received in our - Suggestions Section -. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently and precisely as specified in the User Requirement Specifications (URS).

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


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Climatic Controlled Zone PQ (Issue 4)
$89.00
10000408
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

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Package Climatic Zone Validation. Level-4 (Issue 3)
$475.00
10000424
If your requirement is to validate a cold / hot climate controlled cabinet or room that is used within a facility that is fully validated and subject to change control and you do not need to purchase temperature and humidity recorders, then this package comes without hardware.
In this case you only require the following validation protocols;
VP, VRA, IQ, OQ, PQ.
This package consists of one of each of these documents.

Quantity   
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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21 CFR Part 11 Eligibility Verification (Issue 3.)
$16.00
11000163
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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21 CFR Part 11, Verification (Issue 3.)
$26.00
11000164
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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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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Cabinet Temperature Mapping (Issue 4.)
$16.00
11000169
This test script is used to verify that whenever product is stored or processed at a specified temperature, within a enclosed area, all of the product is subjected to the same temperature and that the temperature at all times remains within the process specified limits.

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Change and Consumable Parts Verification (Issue 3.)
$16.00
11000170
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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Critical Area Material of Construction Verification (Issue 1.)
$16.00
11000171
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 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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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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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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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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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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Software Quality Verification (Issue 3.)
$16.00
11000190
Test script 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 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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