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.
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.
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 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
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.
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
This quite unique 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.
For Your Security We are Now TLS 1.2 Compliant
This document follows our indigenous method of using a generic document to guide the customer in applying an integral SOP to convert the generic document quickly into a first-class company bespoke validation plan (VP); sometimes termed, Quality Plan (QP). This VP details and integrates all validation activities and procedures required for a validation project. It may be a minor document for small modifications and installations. At times it may be a very involved document for large projects.
The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.
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
This VRA now includes the assessment table for categorising 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).