Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Electronic Records Enforcement Relaxed During Part 11 Review, FDA Says

This article was originally published in The Tan Sheet

Executive Summary

FDA intends to relax enforcement of its Part 11 regulation on electronic records while it reexamines the rule's application, a 1draft guidance published Feb. 25 states
Advertisement

Related Content

FDA Will Propose Drug GMP Quality Management Systems By December
FDA Will Propose Drug GMP Quality Management Systems By December
FDA Will Propose Drug GMP Quality Management Systems By December
Third Party Storage Of Electronic Clinical Data Suggested By PhRMA
Third Party Storage Of Electronic Clinical Data Suggested By PhRMA
Third Party Storage Of Electronic Clinical Data Suggested By PhRMA
GMP Dispute Resolution Pilot Proposed To Evaluate Three-Stage Process
Part 11 guidance withdrawn
PAT Guidance Will Draw From Existing Electronic Records Guidances

Topics

Advertisement
UsernamePublicRestriction

Register

PS095214

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel