German translation: Bestandsbewertung / Inventarbewertung
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English to German translations [PRO] Law/Patents / 21 CFR 11 requirements
English term or phrase:inventory assessment
This is how a 100-page presentation starts.
This involves collecting information about each system/application defined in the process for inventory. This includes System Identification, Demographics, Responsibilities, Quality System Determination and Part 11 Applicability.
Examples of Systems to be inventoried include, but are not limited to:
All multi-user systems, applications and laboratory or manufacturing equipment involved in US FDA regulated activities and/or submissions. All single user systems that are validated (quality related) or identified for validation must also be inventoried.
The presentation deals with a program for implementation and compliance issues with 21 CFR 11 (regulation regarding electronic records and electronic signatures in systems involved in activities regulated by the FDA).
Explanation: Aus dem Text ist nicht ersichtlich, dass es sich bei diesem Schritt um eine Bewertung handelt; vielmehr geht es m. E. darum ein Inventar aller Systeme (und teilweise Prozesse) zu erstellen.
kostan Austria Local time: 23:52 Native speaker of: German, English PRO pts in pair: 489
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