The use of a professionally Validation packages, or suites of documents is a simple way of ensuring that your visiting regulator's first impressions will be favorable. Inspectors expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. This is the reason why eight years ago; when we ran a questionnaire on our site, two requirements stood head and shoulders above all else;1. Complete Documentation Packages.
The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated.
After due diligence is used to review the current Good Manufacturing Practice (cGMP) legislation (21 CFR Part 11/210/211/820) along with the FDA guidance documents (not mandatory but probably advisable) it becomes rather obvious why there is cascade of documentation and why each document in this cascade is obligatory.
At this stage it becomes rather obvious that the suite of documents we produce is exactly what the regulators expect to find already in place. These documents sequentially cascade from the URS through VRA, DQ, IQ, OQ, P1Q and finish with the P2Q. This progression is of the utmost importance since the documents are inter-referenced and must be executed sequentially. This is one of the main reasons why it is important that the documents are designed and written as a package where the correct sequential and chronological sequences can be authored in; across all the relevant documents.
Validation Documentation Suites.
Numerous validation inquiries led us into collating various validation documents to form validation suites containing all the required protocols; along with the supporting documents, such as the VP and the VRA. This simplifies the user selection task. The packages have been arranged for three levels of validation for process, production, facility and utility equipment and separate bespoke packages for Software, HVAC, Networks and other stand-alone systems.
The complete chain of regulatory required documentation required to enable satisfactory for for the validation of a computer / DCS / PLC / ERP, system. This Validation Package contains one of each of these documents VP - URS - DQ - VRA - IQ - OQ - PQ.
HVAC New System Qualification Package
This package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. Therefore we start with the VP and progress to the URS - VRA - DQ - IQ - OQ and PQ.
HVAC Validation Package.
The complete suite of DQ, IQ, OQ and PQ are bundled here for the end users ease of ordering, also allowing a discount for the multi-document purchase.
You want to validate a relatively minor, new or replacement piece of equipment that is going to be used within a facility that is fully validated and subject to change control.
In this case you require :- IQ, OQ, PQ.
You want to validate a process line that has been subjected to major modification, but is validated and is continuing to use the same processes to produce the same product.
In this case you require: VP, URS, IQ, OQ, PQ.
You have a new facility and you want to validate it. In this case you require:-
VMP, The global master plan for the whole facility.
cVMP, The master plan for all computer systems. VP, which will define validation boundaries, methodologies and responsibilities.
URS, DQ, VRA, IQ, OQ, PQ. For each piece of equipment.
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Equipment combined IQ/OQ/PQ Protocol. $159.00
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.
This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word.
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.