Recently our Regulatory Expert Piritta Maunu gave sầu a training session on Annex 15 in nhật bản & was asked this question:"Regarding qualifying environments for compliance with Annex 15, we understvà that FAT và SAT should be done if required by our products or processes. Under what circumstances bởi environmental monitoring systems require FAT and SAT?"Piritta answers:
Although the question came from nhật bản, my answer is based on GAMP 5 recommendations and therefore applicable to other
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However, GAMP tells us this type of testing is not needed for GAMPhường Category 3 or 4 systems unless they are brvà new & extremely complex. Whether FAT is needed for Category 5 systems that are dependent on the system type, novelty, và complexity.
Factory Acceptance Training is not performed for a lltb3d.com monitoring system because its components are separate, off-the-shelf products, và they are neither new nor complex. Also, we can"t assemble your monitoring system at our factory, so there is really nothing lớn thử nghiệm. The tests that ensure the system performs as expected are covered by the Installation Qualification & Operation Qualification protocols.
Site Acceptance Testing (SAT) should be performed if such tests are included in your chất lượng system requirements. ISPE GAMP 5 defines SAT as a process that shows the system khổng lồ be working as expected in its operational environment. The tests show whether the system interacts correctly with all other systems at the site. For example, in SAT you compare the delivery to lớn your purchase order to lớn see that you have sầu received the correct software and hardware components.In addition, SAT can also contain documentation or verification of any configurations you"ve done. If you have sầu a Configuration Specification (a type of Design Specification that includes items such as system web11_user names, phone numbers, email addresses, threshold limits, delays và comments related lớn alarms etc.), you verify that your system is configured correctly according khổng lồ your requirements. Obviously, SAT cannot be performed without knowing your specific system configuration requirements.
Going baông xã lớn the original question, which was asked by a Japanese customer, per Japanese GAMPhường. guidelines, thiết kế specifications and acceptance tests are not required for a Category 3 system. Refer to Appendix 2 of the Japanese guideline: here is the English translation provided for reference only from Japan"s Pharmaceuticals & Medical Devices Agency (PMDA):
Tentative Translation August 17, 2011, Ministry of Health, Labour và Welfare
Guideline on Management of Computerized Systems for Marketing Authorization Holders & Manufacturers of Drugs and Quasi-drugs
Additionally, we recommover that you document configurations as you create them in order khổng lồ get an overview of how you are configuring your system. By documenting your configurations, you ensure that you have sầu a record to lớn check for changes later on if the system changes.
To ensure we have a good understanding, refer also to the EU GMP.. Annex 15 on Qualification và Validation as it outlines FAT và SAT. (This guidance has been in operation since October 2015)
Factory acceptance testing (FAT) /Site acceptance testing (SAT)
3.4. Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior lớn delivery.
3.5. Prior to installation, equipment should be confirmed to comply with the URS/functional specification at the vendor site, if applicable.
3.6. Where appropriate và justified, documentation đánh giá và some tests could be performed at the FAT or other stages without the need khổng lồ repeat on site at IQ/OQ
if it can be shown that the functionality is not affected by the transport & installation.
3.7. FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.
As always, we appreciate your questions và comments in the fields below. And feel không tính phí to lớn tin nhắn if you have further questions!