Medtech Insight is part 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


Part 11 Audit Trails, Legacy Systems Subject To FDA Enforcement Discretion

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers must continue to validate electronic recordkeeping and signature systems under ongoing FDA part 11 enforcement discretion, according to CDRH International Staff Director Christine Nelson

You may also be interested in...

Part 11 Risk-Based Approach To Be Communicated To FDA Field Staff

Device manufacturers should prepare for variability in how inspectors interpret Part 11 requirements as FDA gears-up to communicate more specific guidelines to its field staff in the next several weeks

FDA Eases Up On Part 11 Scope, Pulls Old Guidelines

FDA will scale back enforcement of its electronic records and signatures rule (Part 11) for all FDA-regulated products while it reassesses the regulation in light of the agency's current good manufacturing practice initiative for drugs and biologics

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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