Computer Systems 2020 - 21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA

ERP Project Manager, City of Richmond
The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.
We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.
Part I The Keys to COTS Computer System Validation 1 hour
The Keys to COTS Computer System Validation
“GxP” Computer Systems
Regulatory Oversight
Software Categorization
“COTS” Software
“Cloud” Solutions
SaaS Solutions
Speaker:
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries.