Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.467
/ Documenti scaricati: 32.316.113
/ Documenti scaricati: 32.316.113
This guidance is intended to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Title of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11.
Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 29 PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1).
The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 31 11) are referred to in this guidance document as predicate rules.
FDA
Com. 2017/C 267/02 del 11 Agosto 2017
Comunicazione della Commissione nell’ambito dell’applicazione del regolamento delegato (UE) n. 665/2013 della Commissione che...
ID 23793 | 10.04.2025 / Documento completo in allegato
Il documento illustra i contenuti della norma UNI 11720:2025 “Attività professionali...
Safety Integrity Software Tool for the Evaluation of Machine Applications
Rilasciata da IFA la Versione stabile di SISTEMA 2 (2.0.8 Build 4) del 05 febbraio 2...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024