Quality Steam Qualification.

In order to induce a machine shop to manufactured these tubes for us; we have to order quantities that are greater than our auditors recommendations – so a very attractive discount is being offered for the expansion and pitot tubes complete with the brilliant fully detailed IQ/OQ/PQ protocol. This offer will only last until our stocks are back within our auditors requirements. $836.00 discounted to $499.00. Quality Steam Validation Kit. -- $499.00 add_to_cart.gif view_cart.gif

Discounted Steam Quality Kit includes all below:

Combined IQ/OQ/PQ Protocol for Quality Steam 10000151

This is a very detailed and comprehensively scripted protocol.  All the test scripts required for IQ/OQ/PQ execution are in place ready for editing to represent your installation exactly.  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. 

Pitot Tube (Issue 2.) 3526998-1

The Pitot Tube is an essential part of the superheat test and the dryness fraction test. All other parts are standard laboratory supplies, which are available from your local laboratory supplier. It is the lack of these parts which forces many companies to contract out the Steam Quality tests, well now you can bring these tests under your own control. These parts are manufactured to a design approved and used by the Health Service.

Expansion Tube (Issue 1.) 3526998-2

The Expansion Tube is an essential part of the superheat test. All other parts are standard laboratory supplies, which are available from your local laboratory supplier. It is the lack of these parts which forces many companies to contract out the Steam Quality tests, well now you can bring these tests under your own control. These parts are manufactured to a design approved and used by the NHS.

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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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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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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Combined IQ / OQ Protocol.
New from Validation Online a Combined almost ready to use; IQ-OQ protocol. Designed to cover equipment in general and specifically laboratory type equipment, with or without embedded or programmable software. This is not a list of chapter headings. It is a fully detailed interactive IQ and OQ protocol.


Combined_IQ-OQ_Issue-1 -- $125.00
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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 $22.00.
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Free Validation Document Downloads

Click Here for further details of CAPA AUDIT document.

VALIDATION ON LINE DOCUMENT STORE


CLICK HERE FOR FURTHER DETAILS OF DOCUMENTATION AVAILABLE
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