Training Doyens

OVERVIEW The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11 regulations.  This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing pa...

Pharmaceuticals and other FDA regulated industries need to ensure that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with FDA 21 CFR Part 11. Our upcoming webinar discusses how to plan, execute or manage the implementation of any system governed by FDA regulations that uses ER/ES capability using cost-effective methods, techniques and tools. The webinar covers the following key areas: ·          Gain an understanding of  FDA’s 21CFR Part 11 Electronic Records/Electronic Signatures (ER/ES)  guidance document ·          Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization ·          Learn how to develop the appropriate computer...

OVERVIEW The webinar will focus on the importance of ensuring that electronic record/electronic signature  (ER/ES)  capability built into FDA-regulated computer systems meets compliance with  FDA 21 CFR Part 11 . This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for chan...