Slide background




FDA 21 CFR part 11 Guidance for Industry

ID 3204 | | Visite: 3792 | Documenti normazione ENTIPermalink: https://www.certifico.com/id/3204



Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application

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

Descrizione Livello Dimensione Downloads
Allegato riservato FDA 21 CFR part 11 Guidance for Industry.pdf
FSA 2003
43 kB 17

Tags: Normazione FDA

Articoli correlati

Ultimi archiviati Normazione

UNI EN 1493 2023  ollevatori per veicoli
Mar 20, 2023 16

UNI EN 1493:2023

UNI EN 1493:2023 / Sollevatori per veicoli ID 19273 | 20.03.2023 / Preview in allegato UNI EN 1493:2023 Sollevatori per veicoli La norma si applica ai sollevatori per veicoli fissi, mobili e spostabili non previsti per il sollevamento di persone, ma progettati per sollevare il veicolo completo,… Leggi tutto
Mar 20, 2023 11

UNI 9167-2:2023

UNI 9167-2:2023 / Alloggiamenti, impianti di controllo stazioni di controllo della pressione gas - Progettazione, costruzione e collaudo ID 19271 | 20.05.2023 / Preview in allegato UNI 9167-2:2023Infrastrutture del gas - Stazioni di controllo della pressione e di misura del gas, connesse con le… Leggi tutto
CEI EN IEC 61851 1 2019
Mar 12, 2023 149

CEI EN IEC 61851-1:2019

CEI EN IEC 61851-1:2019 / IEC 2017 Sistema di ricarica conduttiva dei veicoli elettriciParte 1: Prescrizioni generali Classificazione CEI: 69-7Data pubblicazioneE: 2019-09 La presente Norma si applica alle apparecchiature di alimentazione per veicoli elettrici per la ricarica di veicoli elettrici… Leggi tutto

Più letti Normazione