What is Equipment Qualification ?
The Equipment Qualification is a process of ensuring and documenting that any equipment under GxP environment operates and
produces the consistent and reliable outputs.
In documental format the equipment qualification is a process of verifying, that any GxP equipment is installed , operates and
performs as per user requirements stated in an approved URS
It also involves verification of design components through Design specification , Factory Acceptance and Site acceptance
USFDA, EMA,WHO, TGA And
CDSCO
Detailed Protocol for
Qualification with execution
Detailed Workflow with All Test
Reports
FAT, SAT and DQ
We specialize in providing robust Equipment and Process Validation services tailored to meet the rigorous demands of highly
regulated industries such as pharmaceuticals, biotechnology, healthcare, and medical devices. Our validation services ensure that
both equipment and processes comply with international regulatory standards, including those set by the US FDA, EMA, WHO, TGA,
and CDSCO.