Follow us on LinkedIn

21 CFR PART 11

Friday 1 August 2003

The FDA regulations on electronic critical data and electronical signatures: a reference for the pharma world.

FDA (Food and Drug Administration) recalled some guidelines for the implementation of the 21 CFR Part 11 on electronical records and signatures for pharmaceutical companies and  substituted them with a new version of the 21 CFR Part 11.


This revision is less restrictive and is focused to facilitate the introduction of new technologies in the pharmaceutical industry. For example, in hybrid systems, where data are collected both in hardcopy and electronic archive, the application of 21 CFR Part 11 is not mandatory anymore.


However, it’s important to be cautious: FDA explicitly when and where it will be discretional in verifying the conformity to 21 CFR Part 11 regulations.


Read more: read an article about the new interpretation of 21 CFR Part 11 (ITA).

Ask for a consultancy


 < Back

Adeodata S.r.l.
Via E. Mattei, 2

22070 Bregnano (CO)



Registered office: Via Carducci, 32 — 20123 Milano

VAT Nr. 05617310965    REA 1834791 Milano   PEC

Adeodata SA
Via Calgari, 2

CH 6900 Lugano

IDI CHE-112.203.579

© 2019 Adeodata. All rights reserved.

Designed and developed by Carrara Communication