Data Integrity and Governance for Computer Systems Regulated by FDA

During this webinar, we will focus on the importance of ensuring that both structured (e.g., database records) and unstructured (e.g., Word document, PDF, spreadsheet) data are maintained with integrity through their chronological life cycle. This requires recognition that FDA is laser-focused on data integrity issues based on industry inspection trends during the past decade.

FDA’s Guidance for Data Integrity, issued in December 2018, did not include a single new requirement. Instead, it reiterated parts of the Code of Federal Regulations (CFRs) that have been in place for decades, and which industry was failing to meet.

Why You Should Attend:

This webinar will help you understand FDA’s guidelines for validation of computer systems, and develop an appropriate validation strategy. This includes ensuring a system is maintained in a validated state through its entire life.

The SDLC will provide a framework for validation planning, allowing the attendee to understand all of the phases and deliverables required during validation. The end result will be a very well documented validation effort that will stand up to FDA scrutiny during an audit, and assure that the data housed and/or processed using the validated computer system will be maintained with great integrity.

It is important to remember that in addition to validating a computer system subject to FDA compliance, the system must be maintained in a validated state throughout its lifecycle, until the system is retired or otherwise no longer used. This webinar will describe the policies, procedures, training and other underlying support elements that are needed to ensure ongoing maintenance of a system in a validated state.

With FDA resources heavily focused on inspection targeting both data integrity and ER/ES, this webinar will provide insight into meeting compliance, following a streamlined, cost-effective approach. We will discuss FDA’s requirements and provide examples of FDA citations. You will also learn about current industry best practices that will help you mitigate potential risk.

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.