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.
The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. It must mandate the production of all Practices and Procedure manuals and SOP's.
The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.
When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation. 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 rulings.
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