본문 바로가기 주메뉴 바로가기

사업분야

home > 사업분야 > Validation

사업분야

BUSINESS AREA

Validation

Validation & Documentation

검증은 GMP 프로젝트의 필수 요소

Validation Master Plan = VMP / VP

Validation / Qualification / Testing (FAT / SAT)

  • - DQ (Design Qualification – URS, RA, FS, DS)
  • - IQ (Installation Qualification)
  • - OQ (Operational Qualification)
  • - PQ (Performance Qualification)

Documentation

  • - Protocol / Report
  • - Summary Report

SOP’s

GMP support

  • - Review
  • - Change Control
  • - Deviation

Calibration