As technology keeps advancing quickly, there is a growing need for Computer System Validation, compliance with 21 CFR Part 11 (Electronic Records and Electronic Signatures), and strong data integrity in environments where AI is becoming common.
Over the past decade, the FDA has raised concerns about poor compliance with data integrity and Part 11. Citations such as Form 483s and Warning Letters have increased sharply. The main reason is that many employees are under pressure to do more work with fewer resources and less time. This often leads to rushing, mistakes, and in some cases, shortcuts that can even result in fraud. At the same time, this challenge creates opportunities to discuss using AI and other technologies in software development, testing, and support. The focus is also on improving efficiency by following CSA, which removes work that does not add value while ensuring risks are properly managed.
With technology and compliance both changing rapidly, it is important to be prepared and use these advances to deliver safe, high-quality products that meet consumer needs. Both the FDA and industry remain focused on public safety by providing newer, safer, and more effective products.
Life science industries—including pharmaceuticals, medical devices, biotechnology, biological, tobacco, and related products—are adopting new technology to improve product quality while staying in compliance. Many companies are now moving toward cloud-based services, SaaS solutions, and other technical innovations. More recently, we see the growing use of Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs) like ChatGPT in these industries.
While life science companies have been slower than others to adopt these tools, they are now catching up. AI is increasingly being used in product development, testing, release, and management to ensure quality and compliance. This is especially visible in the medical device field, where products often include software or are entirely Software-as-a-Medical-Device (SaMD). Ensuring Cybersecurity in CSV is also becoming critical as these technologies expand.
Computer System Validation remains a key requirement to balance innovation with compliance in this fast-changing landscape.
Areas Covered in the Session:-
This webinar includes the following key objectives:
Why You Should Attend:-
Providing safe and effective medical devices, drugs, and other FDA-regulated products is essential for everyone involved in their development, manufacturing, testing, and distribution. Current industry pressures—such as rising healthcare demand, the growth of specialty medicines, and physician shortages—require strategies to reduce strain and speed up the delivery of safe and effective products to the market. As demand
grows and cases become more complex, quick access to accurate information is critical to maintaining quality.
To meet these challenges, the industry must adopt innovative technologies. FDA has also started pilot programs using new technologies and is working on regulatory frameworks to ensure products remain safe and effective. Discussion papers issued over recent years, updated based on stakeholder feedback, will guide the future of compliance and product quality.
In this webinar, we will compare traditional Computer System Validation (CSV) with Computer Software Assurance (CSA), as outlined in FDA’s September 2022 draft guidance. We will also cover updates in GAMP®5, 2nd Edition and how these align with CSA. While CSA is still draft guidance, it is expected to be finalized soon, and companies need to be prepared.
We will discuss how AI in CSV and other technologies can improve efficiency, effectiveness, and quality throughout the software development life cycle (SDLC), helping deliver reliable computer solutions that meet industry needs. The session will also cover FDA compliance trends, including the increase in citations over the past decade for 21 CFR Part 11 (electronic records and signatures) and data integrity issues (ALCOA+ principles). Special focus will be given to laboratory areas, including audit trail management, risk assessment, access controls, and security.
Finally, we will introduce Validation 4.0 concepts and provide guidance on preparing your company for CSA and FDA inspections, ensuring your processes remain compliant while leveraging technology for better outcomes.
Who Should Attend:-
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Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device, and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.
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