Nicolet iS10 FTIR Spectrometer Brochure

• Design Qualification documentation (DQ) • OQ, PQ protocols and documentation • Installation Qualification (IQ) also available Digital signature and electronic data security (optional) • Complete 21 CFR Part 11 compliance tools • Digital signatures for the most secure data • Audit trails for data and system use

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薬食監麻発 平成22年10月21日 厚生労働省医薬食品局監視指 …

薬食監麻発1021 第11 号 平成22年10月21日 各都道府県衛生主管部(局)長 殿 厚生労働省医薬食品局監視指導・麻薬対策課長

INTRODUCTION A Tl 857 ULTRAVIOLET-VISIBLE SPECTROSCOPY

application from selection to instrument retirement: design qualification (DQ); installation qualification (IQ); an initial perform-ance-to-specification qualification, also known as operational qualification (OQ); and an ongoing performance qualification (PQ). For more details, see Analytical Instrument Qualification á1058ñ.

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システム/機能の特定と品質リスクマネジメント（QRM）手 …

計時適格性評価（dq）、据付時適格性評価（iq）、運転時適格性評価（oq）、性能適格性評価 （pq）を個々にまたは組み合わせて実施すること」と述べており、この定義は製剤に対しても適 …

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