Thai Donor
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Detailed Analysis
Donor pays attention to both the peripheries and the details. He scrutinizes manufacturing, validation, and documentation processes. He pays close attention to the electronic data integrity, including electronic records and signatures. Also, he checks mathematical justifications for certain actions like sampling plans.
Investigator Thai Donor is extremely meticulous, with a keen eye for procedural correctness and conformance to established standards. His earlier 483 inspections reveal a focus on Corrective and Preventive Actions (CAPA) procedures, Device History Records (DHR), process validation, and electronic records and signatures. He also looks for adherence to approved specifications for products as well as the proper justification in cases where non-conformance deviations have been allowed.
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