COMBINED IQ-OQ-PQ PROTOCOL.


IQ OQ PQ combined protocol most popular template on web.


Combined IQ-OQ-PQ protocol.

This graphic displays the cover page of the combined IQ-OQ-PQ protocol.

This combined iq-oq-pq protocol 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 sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by end user.

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 and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently and precisely as specified in the URS.

Equipment Combined IQ-OQ-PQ Protocol (Issue-2). -- $159.00
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This graphic illustrates document cross references.

This Combined IQ–OQ-PQ 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 Combined IQ-OQ-PQ 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 and all test scripts are fully documented and referenced.

Validation Online documents should never be confused with the routine document templates available on the internet. These templates are mainly little more than a list of chapter headings. Where as, Validation Online documents are of a unique interactive design which has been developed over the last ten years. Ten years during which regulatory compliant documentation has been successfully supplied to over sixty countries.

Our unique design was developed by a team of pharmaceutical consultants working across the pharmaceutical, medical device and biotechnical industries. These consultants covered all the validation disciplines and collectively pondered long and hard to come up with a design that would be acceptable to all users and highly cost effective for companies.

Now this new combined IQ–OQ protocol brings a refreshingly simple and attractive approach for the industry professional, enabling them to raise professional quality validation protocols in a very efficient and cost effective manner.



Validation Online documents should never be confused with the routine document templates available on the internet. These templates are mainly little more than a list of chapter headings. Where as, Validation Online documents are of a unique interactive design which has been developed over the last ten years. Ten years during which regulatory compliant documentation has been successfully supplied to over sixty countries.

Our unique design for the combined IQ-OQ-PQ protocol was developed by a team of pharmaceutical consultants working across the pharmaceutical, medical device and biotechnical industries. These consultants covered all the validation disciplines and collectively pondered long and hard to come up with a design that would be acceptable to all users and highly cost effective for companies.

Now this new combined IQ–OQ-PQ protocol brings a refreshingly simple and attractive approach for the industry professional, enabling them to raise professional quality validation protocols in a very efficient and cost effective manner.


VALIDATION DOCUMENTS & PROTOCOLS.

The V chart shown below indicates the relationship between the various validation documents and protocols. It can be easily recognised that each of these documents and protocols play an essential role in the validation task. All these documents must be considered mandatory in the majority of instances.


Essential protocols and documents include, the IQ, OQ, DQ and the PQ, along with the essential VMP, VP, URS, VRA

This schematic illustrates the basic V structure that the regulators insist is used.


This schematic diagram shows the inter-relationship of validation documents.


COMBINED IQ-OQ-PQ


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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer 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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Equipment combined 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 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 and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.

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

Validation Risk Assessment.

It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download. This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments as this is now a mandatory requirement.



Validation Risk Assessment (Issue10.) -- $125.00
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