This combined IQ OQ PQ protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. This integrated protocol 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 the end user.
The IQ section in the combined iq oq pq document 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 of this jointed protocol 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 of this jointed protocol gives documented verification that the equipment performance in its normal operating environment is consistently and precisely as specified in the user Requirements Specification (URS).
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 verification's 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 combined IQ-OQ-PQ design was developed by a team of pharmaceutical consultants working across the pharmaceutical, medical device and bio-technical 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.
The V chart shown below indicates the relationship between the various validation documents and protocols. It can be easily recognized 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.
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.
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
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.