FAT or SAT; usually the FAT or Factory Acceptance Testing is executed at the vendors test facility and the latter; the SAT or Site Acceptance Testing is executed at the clients site. The FAT document must be written to fully challenge the Functional Specification (FS) that was derived originally from the User Requirements Specification (URS). Regulatory compliance protocol documentation standards must be used for writing the FAT. The intimate and detailed knowledge required to write the FAT; dictates that the vendor should write it. The SAT is a slightly less onerous document but still challenges all aspects of the equipment under qualification.
It is actually criminal that having spent hundreds of hours authoring, developing and finally executing a detailed FAT at the factory, the document is often allowed to die and never be used again. For instance in a project Validation Online was closely involved in; 87 people spent nearly one year in raising, approving and executing the FAT for a Distributive Control System, while on site, 30 people spent over a year writing the qualification test scripts. The FAT reviewed and condensed would have done a much better job, partly because it was written by staff, who had direct access to the design staff who designed the DCS, but mainly because it was ready, and should have been freely available from the vendor. The FAT or SAT along with the FT, are the same as the re-qualifying tests that are carried out on laboratory and process equipment. It becomes a little obvious that if these documents were written to normal validation protocol standards, then, the one document could be used for the testing section in documents like, the FAT, FT, qualification and re-qualification of equipment.
Factory Acceptance Tests (FAT)
The FAT protocol is an inspection that includes both static and dynamic exhaustive testing of systems or major system components to support the qualification of equipment or a system. The tests must verify that all functionality detailed in the User Requirements Specification (URS) is embodied and performs as specified. It is written by the manufacturers and executed by the client or client representative.
Site Acceptance Tests (SAT)
The SAT is related to the FAT and also entails inspection and dynamic testing of systems or major system components to support the qualification of equipment. This is written by the client and verifies that the installed functionality of the equipment meets or exceeds the operational requirements as specified in the equipment URS. The SAT is executed on completion of all commissioning tasks; but prior to the start of Installation Qualification execution.
Is it FAT or SAT? In the pharmaceutical, biotech and medical device industries factory Acceptance test and Site Acceptance test documentation are routinely used to ensure that all cGMP requirements are complied with. Requirements that are legislated for mainly through CFR Parts 11/210/211/820 in the USA and in similar legislation through the world. Briefly, it requires all manufacturing of controlled medical products to be compliant with legislation that will give a high degree of confidence that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management.
It should be fully documented and its effectiveness monitored.>All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the manager of the manufacturing authorisation and for the authorised person(s). The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.
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. Resulting in the document becoming notably easier to use and quicker to review and amend. 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 sacrificing regulatory compliance.
This new 4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the these four protocols and carefully weaving them into one notably easy to use protocol, we have made significant progress in reducing validation paperwork. Reductions of up to 75% have been quoted as the likely total. Integrating the old style DQ/IQ/OQ/PQ protocols into one 4Q document will be an enormous savings in man hours in the authoring, reviewing, updating and approving tasks. With the simultaneous introduction of the new Validation risk & Requirements Plan (VrrP) which integrates the VP, VRA & URS into one document - equipment validation has been reduced to two document.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
During a regulatory visit the inspectors do 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. 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