Emerging FDA Trends in Computer System Validation (CSV)

The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.

We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within these companies.

While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.

Why You Should Attend:

Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. Current industry drivers, including the rising demand for healthcare, expansion of specialty medicines & physician shortages require key strategies to alleviate pressures & accelerate the delivery of safe & effective products to the marketplace. As demand surges & complexity of cases requires approaches leveraging the latest medical knowledge, rapid access to accurate information is essential to quality.

Only by leveraging the latest in innovative technology will the industry catch up to where delivery is meeting demand. Along with companies, FDA has begun pilot programs using these technologies and is working to develop the appropriate regulatory framework to ensure products are safe & effective. Several discussion papers have been issued over the last few years & updated based on stakeholder feedback. Ultimately, these will be key elements for driving success.

We will compare traditional Computer System Validation (CSV) with Computer Software Assurance (CSA), the latter of which is the subject of FDA’s September 2022 draft guidance for industry. We will talk about the changes in the newer GAMP®5, 2nd Edition & how these align with CSA. While CSA remains a draft guidance, it will likely be finalized in the near future & companies must be prepared.

In addition to technology, we will discuss a variety of current trends in FDA compliance & enforcement. Over the last decade, we have seen an increase in citations related to 21 CFR Part 11 (electronic records/signatures) & data integrity (ALCOA+ principles) deficiencies. Laboratory areas have been the subject of many FDA findings, particularly around audit trail management & use, risk assessment, access controls & security.

In this webinar, you will learn just how AI & other technologies can increase efficiency, effectiveness & quality of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions that will drive industry over the coming years. We will also discuss the various areas of FDA concern & ways to ensure your company is inspection ready. Finally, we will prepare the attendees for CSA & what to expect from FDA in terms of compliance & enforcement.

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.