Transcription of GMP Audit Report - Pro QC
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GMP Audit Report - Pro QC
GMP Audit Report * Example Report * North America +1-813-252-4770 Latin America +52-1-333-2010712 Europe & Middle-East +49-8122-552 9590 Asia & Asia Pacific +886-2-2832-2990 Email 0 NAME :NAME :ADDRESS :ADDRESS :CITY :CITY :COUNTRY :COUNTRY :PHONE :PHONE :FAX :FAX : : : : : Audit RESULTSPro QC PERSONNELSUPPLIER'S PERSONNEL PARTICIPATING xxxxx-xx-xxxxxxxSUPPLIER'S INFORMATIONCLIENT'S INFORMATIONGMP Audit NameAudit DateReport No. Created by: Champlain, Review by: Marketing, Approve by: GMAudit Summary QSR 21 CFR 820 Audit Form, Rev 0. 2015/11/12 ComplyNeed ImprovementNot #REF!#REF!#REF!#REF! a CAPA before you engage in any - The QMS presents serious major ncf (seeAudit Report ) that could impact youryour business. The better solution is to source from another and Process ControlsJUDGMENT & RECOMMENDATIONSP assed - The QMS is effective; you could use this supplier as a reliable business - The QMS is acceptable with minor ncf (seeAudit Report ); you could use thissupplier as a reliable business partner, but keep pushing them for improvement to reduce - The QMS presents few major ncf (seeAudit Report ); you could request them toIdentification TraceabilityReceiv
1) Certified to ISO 13485, CE, registered to FDA with quality management fully documented. 2) Have a dedicated personnel to ensure conformity to requirements related to medical devices. 3) Very large manufacturing center with 11 workshops in the same place.
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