• Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments
  • Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

    • Speaker : Carolyn Troiano
    • Session Code : CTJUN2824
    • Date : 28th June 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins

10 Minutes excerpt from the recorded event for your review: 

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LinkedIn Article - Mastering Mobile App and Medical Device Software Validation

In this LinkedIn article we've encapsulated the entire session's discussions and insights.



For over four decades, computer system validation has been a critical component under FDA regulation, pivotal in the manufacturing, testing, and distribution processes within pharmaceutical, biotechnology, and medical device industries. The FDA's stringent requirements ensure meticulous planning, implementation, integration, testing, and management of computer systems that handle data crucial to product integrity and safety.


In 1997, the FDA further delineated the framework for Electronic Records and Electronic Signatures (ER/ES) through the guidelines set forth in 21 CFR Part 11. This regulation underscores the fundamental prerequisites for validating and documenting ER/ES functionalities in FDA-regulated environments.


Recognizing the impracticality of inspecting every computer system, the FDA, in the early 2000s, shifted the responsibility to the industry to assess regulated computer systems based on risk. The potential risk of system failure informs the validation strategy and scope, taking into account factors like system size, complexity, business criticality, GAMP®5 category, and risk rating. These components dictate the extent of testing necessary to ensure data integrity and product safety.


Amidst heightened scrutiny on data integrity during validations, the FDA continues to emphasize the management and maintenance of both structured and unstructured data throughout their lifecycle. The rise of interconnected medical devices, including mobile medical devices and Software-as-a-Medical Device (SaMD) solutions, introduces additional layers of complexity and cybersecurity concerns. This has propelled the FDA to the forefront of addressing these challenges, emphasizing the need for robust validation and compliance strategies.


This webinar will delve into best practices and strategic approaches for evaluating computer systems in FDA-regulated activities, focusing on risk assessments and the System Development Life Cycle (SDLC) methodology tailored to GAMP®5 software categorizations. Special emphasis will be placed on the validation of mobile applications and related infrastructure components, including cloud and SaaS solutions. We will cover crucial policies, procedures, and documentation required to maintain compliance and prepare for FDA inspections, ensuring data integrity and cybersecurity are upheld across all platforms.


Areas covered during the session:


This webinar includes the following key objectives:


  • Learn how to identify “GxP” Systems
  • Learn how to identify specific types of mobile devices, including mobile medical devices and Software-as-a-Medical Device (SaMD) solutions and the FDA regulations that apply to them
  • Discuss the Computer System Validation (CSV) approach based on a System Development Life Cycle (SDLC) approach
  • 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
  • Understand the cybertechnology landscape, including cyber threats and measures for preventing, detecting, and mitigating these
  • Learn strategies for meeting 21 CFR Part 11 requirements for electronic records and electronic signatures (ER/ES)
  • Learn how to maintain data with integrity, in accordance with the “ALCOA+” principles
  • 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 about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • 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 for mobile devices and software to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A


Why you should attend?


This webinar is designed to equip attendees with the knowledge to implement the most effective validation strategies for systems utilizing cutting-edge technologies within FDA-regulated environments. Focus will be on mobile applications, mobile medical applications, and Software-as-a-Medical Device (SaMD) products.


Understanding the foundation of any computer system implementation—including the necessary infrastructure of hardware and software—is crucial. This session will explore how to qualify these components to support systems in a validated state. From Commercial-Off-the-Shelf (COTS) packages to cloud services and Software-as-a-Service (SaaS) solutions, you will gain insights into ensuring that all supporting technologies meet rigorous FDA standards.


Additionally, we will cover best practices for validating all types of mobile devices and applications, ensuring they remain in a validated state throughout their lifecycle. By attending, you will not only learn to navigate the complex landscape of FDA regulations but also ensure ongoing compliance and integrity in your systems and applications.


What industries will benefit from this 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, E-Cigarette, Cigar (based on the “Deeming” Act of 2016)
  • Providers of GxP mobile and medical device hardware and software
  • Third-Party companies that support those in the above industries by consulting and other professional offerings


Who will benefit?


Personnel in the following roles will benefit:


  • Information Technology Developers & Testers
  • 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
  • GxP 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 methods 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 Compliance, Mobile App Validation, Medical Device Software, Cybersecurity Medical Devices, Data Integrity, 21 CFR Part 11, Risk Assessment, GAMP 5, SDLC, Cloud Services Validation, Carolyn, Troiano, June 2023, Webinar