Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry
Information
Type
Guidance
Regulated products
Animal & Veterinary, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco
Topics
Administrative / Procedural, Compliance, Current Good Manufacturing Practice (CGMP), Electronic Submissions, Good Clinical Practice (GCP), Postmarket
Published
September 5, 2003
Last updated
September 29, 2023
Description
This document is a guidance for the industry on the scope and application of Part 11, covering topics like compliance, electronic submissions, and good clinical practice.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)