• Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems
  • Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

    • Speaker : Carolyn Troiano
    • Session Code : CTMAR2524
    • Date : 25th March 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins



For over three decades, the FDA has regulated computer system validation (CSV) across pharmaceutical, biotechnology, medical device, and other FDA-regulated industries. This regulation encompasses the comprehensive lifecycle of computer systems involved in manufacturing, testing, and distribution processes, ensuring that these systems are thoroughly planned, implemented, integrated, tested, and managed to uphold data integrity and product safety.


The pivotal guidelines for electronic records and electronic signatures (ER/ES) were established in 1997 under 21 CFR Part 11. This regulation outlines the fundamental criteria for validating and documenting the ER/ES functionalities in FDA-regulated environments, underscoring the critical nature of these digital components in maintaining regulatory compliance.


Recognizing the impracticality of inspecting every computer system across all regulated entities, the FDA, in the early 2000s, transitioned the responsibility to the industry. This shift necessitated a risk-based assessment of all regulated computer systems, with the potential risk of system failure informing the validation approach and planning process. Factors like system size, complexity, business criticality, GAMP 5 category, and risk rating became essential in determining the extent of testing required to ensure the system's integrity and safety.


The FDA's intensified focus on data integrity in recent CSV inspections and audits has spotlighted the compliance of systems involved in regulated processes. Systems that interact with regulated data—including structured data like databases and unstructured data such as documents and multimedia files—are imperative to be managed meticulously to preserve their integrity throughout their lifecycle.


This webinar aims to delve into the best practices and strategic methodologies for evaluating FDA-regulated computer systems, assessing their risk potential on data integrity, product quality, and consumer safety. Attendees will gain insights into the System Development Life Cycle (SDLC) approach to validation, centered on risk assessment, and the critical aspects of managing electronic records and signatures as per 21 CFR Part 11.


Further, the session will navigate the validation and qualification processes for infrastructure components like cloud-based servers and Software-as-a-Service (SaaS) platforms, highlighting the unique approach required for auditing and performing Installation Qualification (IQ) for these systems.


Comprehensive coverage of essential policies, procedures, and supporting documentation will be discussed, equipping attendees with the knowledge to ensure compliance and readiness for FDA inspections. The importance of vendor audits for computer system hardware, software, and services will also be emphasized.


Conclusively, the webinar will present an array of industry best practices focused on data integrity and risk assessment, offering valuable insights to enhance GxP activities across various regulated sectors.


Areas will be covered during the session:


  • Learn how to identify “GxP” Systems
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
  • Learn about cloud service and SaaS providers and the best approach for conducting a vendor audit and performing Installation Qualification (IQ) for validation
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system’s entire life cycle
  • Learn how to assure the integrity of data that supports GxP work
  • Discuss the importance of “GxP” documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA’s current thinking at any given time
  • Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system
  • Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A

Why you should attend?


This webinar will illuminate the path to mastering validation methodologies for systems utilizing cutting-edge technologies in FDA-regulated industries. Attendees will gain a deep understanding of the essential role that IT infrastructure plays in supporting computer system implementation projects, encompassing both hardware and software components.


We will delve into the specifics of on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions, highlighting key considerations such as security, access control, incident reporting, change control, and system maintenance. The session aims to equip you with the knowledge to navigate these elements effectively, ensuring robust support for systems in a validated state.


Furthermore, we will explore innovative approaches to manage hardware and software validation, emphasizing efficiency and effectiveness without compromising quality or compliance. By rethinking traditional methods and leveraging technological advancements and vendor contributions, attendees will learn how to streamline their validation processes.


Join us to discover how to adeptly apply validation principles in a modern technological landscape, enhancing your ability to maintain compliance while harnessing the full potential of new technologies in the FDA-regulated domain.


What industries will benefit from your training:


Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:


  • Pharmaceutical (for drug products introduced using a medical device)
  • Medical Device
  • Biologicals (for biological products introduced using a medical device)
  • Tobacco (based on the Tobacco Control Act of 2009)
  • E-Liquid/Vapor (based on the “Deeming” Act of 2016)
  • E-Cigarette (based on the “Deeming” Act of 2016)
  • Cigar (based on the “Deeming” Act of 2016)
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
  • Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?


  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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Tags: FDA Validation, IT Infrastructure Compliance, Risk-Based Approach, Cloud Computing FDA, SaaS FDA Regulation, GxP Compliance, Computer System Validation, 21 CFR Part 11, FDA Audit Preparation, Technology Validation FDA, Carolyn Troiano, March 2024, Webinar