ALL DOCUMENTS ARE WRITTEN USING MS WORD OR EXCEL. THEY CARRY NO ADVERTS AND ARE 100% EDITABLE. THESE COMBINED PROTOCOLS WERE DESIGNED AND PRODUCED IN RESPONSE TO NUMEROUS REQUESTS FROM CUSTOMERS. THEY ARE VERY POPULAR AND HAVE BEEN REVIEWED BY MOST REGULATORY AUTHORITIES THROUGH OUT THE INDUSTRY (SALES NOW EXCEED 1000). WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.
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IQ/OQ/PQ Protocols Introduction.

All our three part combined IQ/OQ/PQ protocols are written to a common standard with the layout, introduction and table of contents being very similar.  While all the test and inspection stages are purposely targeted at the validation requirements of the specific item under qualification.   The IQ section contains all the standard inspections and tests that you would include in a stand-alone IQ for the same equipment.  The OQ section in a similar manner contains all the standard tests and inspections that are usually included in a stand-alone OQ protocol and the PQ follows the same pattern.  All three sections contain spare test script pages; that can easily be edited to suit any specific additional tests that may be required.  So what do I save in using these three part protocols?

You have the flexibility to edit each section as you deem necessary.  I.E. even although the IQ has many tests and inspections in it; you may decide that the item under qualification only requires minimal IQ attention; perhaps just registration and document verification.  Once you have decided; then you simply edit it down to your requirements.   The main thing from the regulatory point of view is; there is an IQ in place and you have a justification for its contents.  This justification can be and normally is; contained in the VP.  However it can be written into the introduction section of the combined IQ/OQ/PQ protocol. 

 

One document instead of three - just has to be an interesting offer.  There is always instances where one of the three documents (IQ or OQ or PQ) has little or no content.  I.E what is the IQ content for a critical portable test instrument?  What is the OQ content for a critical feed shut? Finally what is the PQ content for a critical holding tank?  Even ignoring these questions; one of the most time consuming; but nearly always overlooked tasks, is the reviewing and approving of protocols.  If you can cut that task by 66% then it must be a big plus.  




Combined IQ/OQ/PQ Protocols.

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Combined IQ-OQ-PQ Computer (Issue-4)

$159.00
10000003
It has been carefully designed to make it the preferred choice in all branches of the industry for the qualification of computers used in embedded / management / Control / Supervisory / Recording roles. It is a very popular 64 page document that can be swiftly and simply edited down for smaller systems or scaled up for larger systems.
The IQ section establishes documented verification that key aspects of the computer adhere to approved design intentions and that the recommendations of the regulators 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 computer performance in its normal operating environment is consistently as specified in the URS.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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Combined IQ/OQ/PQ Equipment. (Issue-5)

$159.00
10000005
This three part document arrives with you fully detailed with all test scripts, rationales and test methods laid out in accordance with regulatory expectations. As can be deduced from the document statistics given below there are sufficient tables included to simplify presentation and enhance the protocol execution phase. The document was specifically designed to be compliant with the all of the FDA, EC and WHO legislation and guidance documentation and over 1700 have been used in submissions to regulatory authorities. This combined IQ/OQ/PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification but it will also produce the thorough audit trail needed to meet all internal or external regulatory reviews and or inspections.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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Combined IQ/OQ/PQ for Spreadsheets. (issue-2)

$159.00
10000022
This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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Combined IQ/OQ/PQ Protocol for Quality Steam (Issue-2)

$185.00
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. All sterilization tasks using steam attract the attention of the regulators. There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user. The power of steam to sterilize is very closely linked to the characteristics of that steam. Routine steam quality testing must be carried out to ensure that your sterilization processes are never compromised. Annual testing of steam automatically attracts auditor attention. Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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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


Quantity   
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Combined IQ-OQ-PQ Software (Issue-3)

$159.00
10000732
This combination protocol has been produced in response to several hundred reader suggestions we received. It has been carefully designed to make it the preferred choice for the qualification of embedded and stand-alone software used in the pharmaceutical, medical devices and bio-technical industries. It is interactive, easy to use and meticulously detailed.
The IQ section establishes documented verification that key aspects of the software adhere to approved design intentions and that the recommendations of the regulators 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 exactly as specified in the User Requirements 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   
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Combined IQ/OQ/PQ Quality Steam (Issue-2)

$565.00
10000736
Here is the chance to bring steam quality testing in house. No one can over emphasis the importance of steam quality. Right now in the medical and pharmaceutical industries are three of the biggest law suites in the whole history of the industry; and all three revolve around adultered steam sanitization processes.
There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user.
The power of steam to sterilize is very closely linked to the characteristics of that steam. Routine steam quality testing must be carried out to ensure that your sterilization processes are never compromised. Annual testing of steam automatically attracts auditor attention. Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB


Quantity   
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WIN KQCL (URS-VP-OQ-OQ ) LAL

$1,650.00
The FDA refused to accept the standard validation package issued by maker. The end user commissioned a consultancy to author the above documents. They were subsequently used many times successfully throughout the corporation. Represents outstanding value for money.


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