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It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and how in your next interview you will know exactly why each one is required. Any project that involves equipment being developed from a third party should have a FAT and SAT incorporated into the system life-cycle.

If both the FAT and SAT are performed correctly is will lead to a much easier IQ/OQ process.

What is a FAT

A FAT or Factory Acceptance Test is usually preformed at the vendor prior to shipping to a client. The vendor tests the system in accordance with the clients approved test plans and specifications to show that system is at a point to be installed and tested on site.

It’s an essential aspect of the whole system lifecycle and should be performed by experienced personnel. Time spent doing a proper FAT will lead to fewer problems when the equipment is installed on your site.

ISPE verdict:

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

GAMP verdict:

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

On acceptance of a FAT some items to look out for include:

  • Performed FAT Protocol
  • Maintenance and User’s manual
  • Recommended spare parts list
  • Certificate of compliance
  • As built technical drawings (electrical, mechanical, pneumatic & process schemes)
  • Materials certificates/data sheets
  • Main equipments data sheets
  • Instruments calibration certificates
  • Welding Processes qualification

What is a SAT

A SAT is a 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.

ISPE verdict:

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)

Below is a list of some items that should be considered when performing a SAT:

  • Finishing Visual check
  • Main components visual check
  • Internal box pressure and ventilation setting
  • Utilities functionality and setting check
  • Functionality/Interlocks Verification (Mechanical & Software)
  • Safety devices and interlocks check
  • Operator’s training

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  • Sotofx

    As important a URS with clearly defined requirements.

    All verifications should satisfy the intended project needs.

    Industries should not find a URS document less important

  • http:euroelec.ie John Loftus

    Very good explanation of the differences

  • alex

    According to this article – Can one consider SAT as actually the “commissioning ” process ?

  • gtf

    A SAT does not necessarily take part of the life cycle process. It cannot substitite the IQ, OQ, PQ documentation. For the aroval of a software a FAT, SAT document cannot substitite the qualification and validation documentation.

  • Koushik Rajaram Nijagal

    Nice explanation, could have been better if given a detailed explanation with an example viz a major processing equipment with the team involved in testing both FAT and SAT, checking against what document, who prepares this master document and who approves etc.

  • S.Vijay kumar

    Your Comment FAT includes broader utility functions which may not be performed either during SAT or OQ.
    For viz the reactor may be provided with VFD for running at different rpm but the application part will be run
    at constant rpm to get the desired quality of the product.This is generally applicable for equipment designed for multiproduct services.

  • joao

    I believe FAT, can anticipate IQ/OQ, and so contibute to fast start on costumer site.Any one can inform if FDA agree with this?

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Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability.

Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

This module is taken from our course on Supplier Qualification.

 

About Us

Learnaboutgmp is a cloud based learning management system (LMS) designed specifically for life science and regulatory organizations. Our LMS contains the courses you need to help you achieve regulatory compliance. With new courses published every month and existing courses updated in line with regulatory changes we are your true continuous learning platform.

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Choosing the correct software for your organisation is a tricky task and even more so when you are working in a regulated environment.

It’s one thing finding a great software package but if the vendor does not take their quality system seriously this could have a dramatic effect on the evolution and robustness of the solution.

They need to take their quality efforts as seriously as you take yours otherwise product quality and patient safety could be compromised.

An overall quality audit should be performed on each vendor before a decision is made, below are a list of questions that you could ask each vendor specifically on their quality system.

If the software vendor does not take their Quality System seriously you need to walk away.

Quality System Questionnaire

  1. Does the company have an established and Documented Quality System?
  2. Does the Quality System adequately reflect the client’s quality engineering policies?
  3. Is the responsibility for Quality defined (SOP)? What are their qualifications?
  4. Is Quality System documentation adequately controlled in terms of review, approvals and distribution
  5. Is the QS documentation regularly updated and otherwise maintained appropriately? (frequency)
  6. Are there procedures for reviewing the performance of the QS e.g. Internal Audit, Management Review?
  7. Are there training procedures and Job specifications? Are these adequate for the Maintenance of the QS
  8. Is there a Quality Plan for the Design, Development and Implementation of the products?
  9. Do the company use Sub Contractor’s?
  10. Do the company have control over any Sub Contractor’s QS? e.g. Vendor Assessment, Specification, Documentation review and approval?
  11. Do the company have access to relevant Sub-contractor Quality documentation?
  12. Is Sub Contractor’s Quality System compatible with the previous questions of this section?
  13. Have the Sub Contractors been audited? Review the report?
  14. Has accreditation/registration been achieved for: BS 5750 Pt. 1 or 2, TickIT, ISO 9000, Other (name
  15. Does the company operate to GAMP for computer systems?
  16. Are there SOPs for QC? Is there a release procedure?
  17. Is there an out-of-specification procedure?

Choosing the correct software application for your organization is a very tricky task and one that takes alot of upfront planning in order to make the correct choice.

The task has even got more difficult with the emergence of cloud based technology and how that impacts the overall validation process.

Remember to outline your requirements clearly and get buy-in from the other business owners.

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