ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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anzuwendende (geltende) Vorschriften

Im Zusammenhang mit Part 11 sind die GMP, GLP oder GCP Vorschriften die anzuwendenden Vorschriften, die die Dokumentation erfordern und definieren, bei der die Firma es vorzieht, diese in elektronischer Form zu halten.

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