Nov 20, 2025 | Drugs, Medical Devices, Seminar, Tobacco
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations that have more recently begun to be used more heavily in life science companies.
Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are beginning to find a presence at 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 more activity related to AI use in software applications used to develop, produce, test, and manage life science products with quality and compliance.
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where artificial intelligence (AI) and machine learning (ML) are becoming prevalent.
FDA became alarmed by the lack of compliance to meet data integrity and Part 11 requirements during the last decade. Out of compliance citations during this period, including Form 483s and Warning Letters have skyrocketed for these key areas of compliance. But why?
Based on discussions with clients and stakeholders at conferences and meetings, it has become more and more obvious that most of the performers in industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done, and opens the door to more conversation around the use of AI/ML in software development, testing, and support.
Nov 20, 2025 | Drugs, Medical Devices, Seminar, Tobacco
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.
Nov 20, 2025 | Drugs, Medical Devices, Seminar, Tobacco
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.
Nov 20, 2025 | On Demand Webinar
Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.
Nov 11, 2025 | On Demand Webinar
Be prepared when (not if) the FDA is at your doorstep for an inspection! This webinar will cover the processes and procedures to have in place to handle any regulatory inspections at your facility, and the set ups, best practices, and tips for personnel throughout the inspection process, ensuring that the inspection goes as smoothly as possible.
Sep 30, 2025 | Foods, On Demand Webinar
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business. These disruptions lead to lost time, spoiled shipments, and unhappy customers. But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
