19_Cold Chain Utilities. at 009_VALIDATION DOCUMENTATION SHOP

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Available - COMBINED IQ/OQ/PQ - Protocols. Available - AUTOCLAVE VALIDATION - protocols. Want our - MONTHLY NEWSLETTER - Sign here. Free - VALIDATION DOCUMENTS - Downloads.

Cold Chain Utilities.

Validation Plan (Issue 8)
$89.00
10000008

This document follows our well developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

Document Statistics

Protocols = 1

Pages = 29

Paragraphs = 688

Lines = 1332

Words = 5571

Characters = 36210

Graphics = 12

Size = 303 KB

Quantity

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

Quantity

Cold Chain Validation Package level-1
$575.00
10000396
The contents of this package (-2) is the five 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 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, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents, but no data loggers.

Quantity

Cold Chain Validation Package Level-2
$1,625.00
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 Validation Risk Assessment (VRA) 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, 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.
Quantity

Cold Chain Validation Package Level-3
$2,575.00
10000398
This package is suitable for rooms and 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, a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) 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. This is now the simplest, most expedient and cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, 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.
Quantity

Cold Chain Validation Package Level-4
$3,966.00
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 - simple.
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. 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.
There are no short cuts - the content of these documents is mandated.
VP, 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.

Quantity

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

Quantity

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

Quantity

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

Quantity