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

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 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 1997 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, or system of record.

Why You Should Attend:

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it. We will discuss streamlined approaches to meeting both Part 11 and data integrity compliance, regardless of your infrastructure environment or method of software development, testing and support.

About the Instructor

Carolyn Troiano

EAS Consulting Group, Independent Consultant

 Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, biologics, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies. She collaborated with FDA and other industry representatives on development of 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn provides consulting and training on related topics to the FDA-regulated industries, ensuring content delivered and assistance provided is based on current trends in FDA compliance and enforcement, as well as industry best practices. These include FDA’s draft guidance for Computer Software Assurance (CSA) and ISPE’s GAMP®5, 2^nd Edition,. In addition, Carolyn continues researching and updating her material based on regulatory frameworks FDA is developing for industry use of AI, ML, and LLMs, such as ChatGPT in the development, manufacturing and testing of regulated products.