A3P

Log in

This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and 21 CFR part 11 electronic Records; Electronic Signatures.

This guidance clarifies, updates, and expands on 11, Electronic Records; Electronic Signatures - Scope and Application 2003 11 and 21 312 812.5 11 XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX XNUMX products.

Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 - Questions and Answers Guidance for Industry

a3p-100pxhaut logo

 fren

Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb here )


  group    administrators A3P
    
& Project Managers

letter   newsletter A3P