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Employee Appraisals.
July 25, 2012

PROPER USE OF THE DQ.

The Design qualification (DQ) is carried out prior to approval being given to start manufacturing the item to be qualified; if and only if, the item to be qualified has yet to be manufactured from this proposed design.

If the item is off the shelf (already manufactured) then the DQ is used to verify that the design of this manufactured item will deliver all the requirements specified in the User Requirements specification (URS).

When the requirement for this item was formalized, a URS would have been raised. This URS would then have been subjected to the execution of a Validation Risk Assessment (VRA). The outcome of this VRA execution produces a documented justification for the scope of validation deemed mandatory and produces a list of all the support documentation that is considered to be essential for this validation exercise to be satisfactorily completed in accordance with current cGMP legislation.

So in your procurement file you will have a copy of this detailed list of support documentation, all of which must be considered an essential part of the procurement. If the item is classified; for validation purposes, as high risk, there could be a requirement for documentation that the item manufacturer does not supply I.E. detailed drawings, logic flows, software code, etc. If you decide to purchase anyway, then you are deciding that the company will fund the production of these missing documents. Be aware that this can often exceed the cost of the item being validated.

The regulators expect to see that you are using a risk assessment that produces a documented justification for the scope of validation you are applying. They expect to be able to review these documented justifications.

The flow of documents from the VMP to the PQ is progressive and comprehensive in the validation world. While the VMP is the showcase detailing how the company has integrated cGMP into all its activities; the VP is the real workhorse. The VP is used to shape and design each validation project. it defines responsibilities, scopes, timelines, access, boundaries testing limits and expectations. Once approved it becomes the controlling authority for the protocol authors.

The FDA have stated that over 80% of validation problems originate from faulty procurement strategies.


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Climatic Zone Validation Package-1 (Issue 1)
$1525.00
10000399

This package is 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 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) 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.
Includes VP, VRA, IQ, OQ & PQ. Along with 10 RH & Temp EL-USB-2 data loggers.

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Climatic Zone Validation Package-2 (Issue 3)
$2575.00
10000398

This package is 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 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) 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.
Includes VP, VRA, IQ, OQ & PQ. Along with 20 RH & Temp EL-USB-2 data loggers.

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Combination IQ/OQ/PQ Protocol.

Combination IQ/OQ/PQ Protocol.

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 an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by the end user. It has become a very popular document.

Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
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SOP Security.


A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)

Do use a Gap Analysis and avoid these embarrassing events. Gap Analysis Tool (Issue 2.) -- $115.00

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Validation Risk Assessment (Issue10.) -- $125.00


This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.


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Are you ready for an inspection?

With HEPA filters, the manufacturers recommended 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. Regulators ask to review your writen justification for these filter change PD's; make certain you have them.

Purchase your copy of this test script now at Special Price of $16.00.
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The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $ 22.00.

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Some of Our Current Fast Moving Documents.


Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
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Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
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Software Validation SOP (Issue-2) -- $22.00

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Software Validation Master Plan (issue-2) -- $115.00
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Software Validation Risk Assessment (Issue 2) -- $125.00
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Software User Requirements Specification. (Issue 2) -- $115.00
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Software Validation Plan (Issue 2) -- $89.00
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Software Design Qualification. (Issue 2) -- $89.00
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Software Installation Qualification. (Issue 2) -- $89.00

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Software Operational Qualification. (Issue 2) -- $89.00
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Software Performance Qualification. (Issue 2) -- $89.00
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Software Validation Package (Issue 1) -- $699.00
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GO TO:- VALIDATION ONLINE DOCUMENT STORE


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