Pharmaceutical Good Manufacturing Practice Regulations Article 101
Manufacturers shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.If the agreed customer requirements allow installation to be performed other than by manufacturers or their authorized agents, the manufacturers shall provide documented requirements for installation and verification.Manufacturers shall maintain records of installation and verification performed by manufacturers or their authorized agents.
中文原文 藥物優良製造準則第101條
製造業者應於必要時建立包括醫療器材安裝與安裝查證允收準則之書面要求。
製造業者同意顧客之要求，由製造業者及其授權代理人以外之人員安裝醫療器材者，製造業者應提供安裝與查證之書面要求。
製造業者應維持由製造業者或其授權代理人完成之安裝與查證紀錄。
製造業者同意顧客之要求，由製造業者及其授權代理人以外之人員安裝醫療器材者，製造業者應提供安裝與查證之書面要求。
製造業者應維持由製造業者或其授權代理人完成之安裝與查證紀錄。