Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.
In terms of Project Management, we’ll discuss the five (5) phases:
In addition to covering the basic project management phases and best practices, we will discuss techniques for taking a project management approach to validating a computer system regulated by FDA. The webinar will walk you through the validation process, following a System Development Life Cycle (SDLC) approach to validation and maintenance of a system in a validated state. The phases of project management will be shown to align with the phases of validation. This will also include discussion of 21 CFR Part 11 (electronic records/electronic signatures) and data integrity compliance.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities based on size, complexity, business criticality, GAMP®5 category and risk assessment. The system risk is measured by the probability, severity, detectability and mitigation available in the case that a system fails, looking specifically at impact on data integrity, process and product quality, and consumer/patient safety.
We’ll cover the latest draft guidance from FDA on Computer Software Assurance (CSA), a risk-based approach using critical thinking as a driving factor for validation. We’ll talk
about the newest GAMP®5, 2nd Edition and how it aligns with CSA. We’ll also cover the thoughts from GAMP®5 and CSA for moving toward non-linear forms of software development, including agile, artificial intelligence (AI), machine learning (ML), and others.
We will cover the approach for validating/qualifying all components of FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors, and we’ll provide the roadmap.
In addition to taking a project management approach to validation, we will provide an overview of how to use Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT to facilitate the process. Use of ChatGPT, in particular, will be discussed as a component of the project management approach to validation.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.
Why should you attend :
roviding safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the Q-Submission program providing industry with pathways for engaging FDA early for feedback to aid in product development.
We will cover all of the components of the Q-Submission program, including the requests for various types of meetings and letters to gain insight into the FDA’s current thinking on the subject. We will describe the eSTAR program, accessed through the FDA’s portal and integrated with the Q-Submission to facilitate the process.
With newer technologies such as AI in the mix, it means opportunity for greater efficiency and efficacy, but also poses more challenges for companies that develop, test, and support software applications in the life science industries.
In this webinar, you will learn just how AI, ML and LLMs, such as ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years. We will discuss the Software Validation and Maintenance process for ensuring these technologies are developed and managed appropriately.
You will learn how FDA is taking advantage of AI, ML and LLMs, such as ChatGPT throughout the submission and review process to shorten the timeframe and bring innovative products to market more quickly.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.
Areas covered in the session:
This webinar includes the following key areas:
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Who should attend this:
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Personnel in the following roles will benefit:
Carolyn Troiano has more than 40 years of experience in the pharmaceutical, medical device, tobacco 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’s expertise includes traditional Computer System Validation (CSV), Computer Software Assurance (CSA), the System Development Life Cycle (SDLC) Methodology (waterfall and agile), 21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures, Data Integrity, and Data Privacy. Her experience spans multiple types of system platforms, software types, and automation tools. She has implemented and validated very large-scale and complex enterprise-wide applications in all GxP areas of operation.
Carolyn provides webinar and seminar training, as well as consulting with life science industry clients. She is an Industry Advisor for InGenious Dataworks and serves as a Compliance Authority for RiskCortex Limited.
