FAT, SAT Application

Hi,
My question is about FAT and SAT.
Is the aplication of this documents only for new designs or is also aplicable to standard equipments?
For example, if I buy a standard tablet press "Single Rotary Press 2200i"
Thanks
Luis

FAT,SAT is an documented testing of equipment witnessed by customer at vendors site and then at users premises before commisioning /installation. So it is applicable to all types of instruments/equipments.

Thank you shrikantgadekar

Dear all,
i woul be thankful if anyone can provide me the basic difference between FAT and SAT ocumentation. i am not much aware of this so i request u guys to tell me about this and how does it vary from DQ? wrt documentation.

FAT Factory Acceptance Test, Usually preformed at the vendor prior to shipping to client. Vendor to test the system in accordance to client approved test plans and specifications to show that system is at a point to be installed and tested on site.

Factory Acceptance Test (FAT)
The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator’s site.

Publication Source ISPE Biopharmaceutical Manufacturing Facilities Baseline® Guide

Factory Acceptance Test (FAT)
(IEEE) An Acceptance Test in the Supplier’s factory, usually involving the Customer.

Publication Source GAMP 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Factory Acceptance Test (FAT)
Inspection and static and/or dynamic testing of systems or major system components to support the qualification of an equipment system conducted and documented at the supplier site.

Publication Source ISPE Commissioning and Qualification Baseline® Guide (March 2001)

SAT Site Acceptance Test, The system is tested in accordance to client approved test plans and specifications to show the system is installed properly and interfaces with other systems and peripherals in its working environment.

Site Acceptance Test (SAT)
Inspection and /or dynamic testing of the systems or major system components to support the qualification of an equipment system conducted and documented at the manufacturing site.

Publication Source ISPE Commissioning and Qualification Baseline® Guide (March 2001)

DQ Design Qualification, Documented verification that the proposed design is suitable for the intended purpose. Usually verified by Subject matter Experts doing a Design Review. The design review evaluates deliverables to ensure they satisfy the specified requirements.

Design Qualification (DQ)
Documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.

Publication Source ISPE Active Pharmaceutical Ingredients Baseline® Guide Second Edition (June 2007)

Design Qualification (DQ)
A documented review of the design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.

Publication Source GAMP Good Practice Guide – Validation of Laboratory Computerized Systems

Enhanced Design Review (EDR)
A documented review of the engineering design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.

Publication Source ISPE Biopharmaceutical Manufacturing Facilities Baseline® Guide

Really you all giving me a great information.

Who authors the FAT and SAT test plans? Does the manufacturer of the equipment write these documents or is it the customer purchasing the equipment?

The Test Plan is usually written by the client with input from Quality. The Test Scripts could be written by the vendor if the client outsources that. The execution is at least witnessed by the client or client representative.

I agree with RR410. Who ever prepare the protocol for FAT or SAT it need to be reviewed & approved by quality dept. of client (equip user) before executing the test plan. If vendor supplied protocol is not complete in opinion of client, he may ask to include additionally required test in protocol.

The documents might be written by the supplier but have to get approved by the customer. The software, devices have to be compliant with the customers specifications (resp. URS).

It would be usual for engineers at the client company to author the FAT and SAT documents.

For FAT in particular, input from the supplier may be highly useful and relevant.

If the FAT work is to be used in a subsequent validation (so as to avoid repeating tests etc) then it should additionally be approved by the functions who would normally approve the validation documents where the repeat tests would be (if they were being done). If the FAT document is to be used in validation, then it is also important to remember that acceptance criteria must be used - so as to state in advance what result means the test has passed or failed.

If correctly approved, FAT documents can avoid a lot of repetition in IQ and OQ. If the test would be performed exactly the same at the suppliers’ site (FAT) and on the client site (IQ or OQ), and there are no changes between the performing of the FAT, and the test result could not change (eg due to dismantling, shipping, re-installation etc), then it would not need doing again.

SAT can be used in exactly the same way as above - with the same points in mind.

Cat

suppose I bought a mchine without doing URS or any sort of protocol. I just bought it and the supplier is asking me to go for a FAT. now, what r the approaches to do that without having any URS or Protocol?? Is it possible?? what if the supplier also do not have any protocol?? any one?

What ever said and done here , I see same queestion is being asked here.
I think we have to follow some standard document.
I request all members to refer this document:

[COLOR=“blue”]BRITISH STANDARD
BS EN :62381 : 2007
Automation systems in the process industry —Factory acceptance test (FAT), site acceptance test (SAT) and site integration test (SIT)[/color]

can you post the link / file also.

Mr.Ashish,

http://www.bsigroup.com/

You can ask above link and get your copy

oh ! Really a delayed reply from my side.

Many Thanks man.

Would I ask Quality to review/approve an FAT or SAT. Erm, no. They are technical documents based on an approved FDS and depending on complexity, multiple DDS. Generally the FAT is a verification that the configuration / build meets the design (if quality want to qualify the design, no problem). Again generally, the SAT is engineering functionality testing that the installed system meets the design parameters. Of course this is all under the assumption of good engineering practices, where GxP critical functionality has been defined and traced from the URS into the FAT/SAT to ensure adequate testing.
Who authors FAT and SAT - the system vendor (working to an approved FAT protocol).
Who reviews / approves - engineering.
Who does the testing - system vendor.
Who does the witnessing - engineering.
Who writes the report and determines system is ready for site / start of qualification - engineering.