• Best Practices in Preparation for an FDA Computer System Audit in 2024
  • Best Practices in Preparation for an FDA Computer System Audit in 2024

    • Speaker : Carolyn Troiano
    • Session Code : CTJUL2224
    • Date : 22nd July 2024
    • Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
    • Duration : 90 Mins



The FDA mandates that all computer systems used to produce, manage, and report on “GxP” (GMP, GLC, and GCP) related products be validated and maintained per specific guidelines. Since the 1980s, when the FDA first issued its guidance on computerized systems, the emphasis on computer system validation (CSV) has grown, reflecting the increasing complexity and criticality of these systems in regulated industries. This webinar will provide an in-depth understanding of the FDA’s current stance on validated computer systems subject to inspection and audit, highlighting areas of heightened scrutiny, particularly higher-risk systems.


The FDA’s guidance on computerized systems, initially issued in 1983, has evolved significantly. Initially focusing on pharmaceuticals, the guidance was expanded to include medical devices. A major development was the introduction of 21 CFR Part 11 in 1997, which established standards for electronic records and electronic signatures, paving the way for a paperless environment while ensuring data integrity and security. This regulation has been periodically updated to balance compliance costs with industry needs, incorporating discretionary enforcement measures to facilitate technological adoption without imposing excessive regulatory burdens.


In response to rising industry findings, the FDA issued additional guidance on Data Integrity in late 2018, addressing critical issues and promoting best practices to ensure inspection readiness. More recently, in September 2022, the FDA released draft guidance for Computer Software Assurance (CSA). Unlike the traditional, document-driven CSV approach, CSA emphasizes critical thinking and risk assessment. This shift aligns with the latest GAMP®5, 2nd Edition, published in July 2022, which supports non-linear software development methodologies, including Agile.


This webinar will also cover the validation of modern systems such as cloud-based services and Software-as-a-Service (SaaS) solutions, as well as automated testing techniques. Participants will gain insights into current compliance and enforcement trends influenced by technological advancements, ensuring their companies remain in a state of inspection readiness.


By understanding the evolution of FDA computer system audits, from their inception to the present day, participants will be better equipped to handle these challenges, ensuring their systems are audit-ready and compliant with current FDA expectations​


Areas covered during the session:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Computer Software Assurance (CSA), Draft Guidance from FDA issued September 2022
  • GAMP®5, 2nd Edition, published by ISPE in July 2022, and alignment with CSA
  • Waterfall and Agile, as Software Development, Testing, and Release Life Cycle Methodologies
  • “GxP” – Good Manufacturing, Laboratory and Clinical Practices
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Data Integrity and the “ALCOA+” Principles (attributable, legible, contemporaneous, original or “true copy,” accurate, complete, consistent, enduring, and available)
  • Data Archival and Governance to ensure security, integrity and compliance
  • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP®5) processes
  • Recent FDA findings and citations for companies in regulated industries
  • The resources, documentation and room preparation necessary to adequately prepare for FDA inspection
  • Q&A


Why you should attend?


Attending this webinar is critical for ensuring your organization's computer systems meet FDA audit requirements and are prepared for inspection. The session will provide detailed insights into maintaining compliance with FDA guidelines, which is essential for avoiding costly regulatory issues and ensuring smooth operational processes.


You will gain a thorough understanding of the latest FDA expectations and how to apply them effectively within your organization. This includes learning about current trends in compliance and enforcement, which are influenced by technological advancements. The webinar will cover best practices for validating modern systems like cloud-based services and Software-as-a-Service (SaaS) solutions, ensuring these technologies are implemented and maintained according to FDA standards.


Additionally, the session will highlight practical strategies for maintaining data integrity and security—critical aspects of FDA audits. By understanding and implementing these best practices, you can ensure your systems are not only compliant but also robust against potential data integrity issues.


Ultimately, this webinar will equip you with the knowledge and tools necessary to position your company in a state of inspection readiness, safeguarding your operations and enhancing your compliance strategies. This proactive approach is vital for staying ahead in the ever-evolving regulatory landscape and ensuring the continued success and reliability of your FDA-regulated systems.


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 Compliance Computer System Validation Data Integrity 21 CFR Part 11 FDA Audit Preparation System Development Life Cycle (SDLC) Computer Software Assurance (CSA) Cloud-Based Services Validation SaaS Validation Inspection Readiness Carolyn Troiano July 2024 Webinar