• FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations
  • FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

    • Speaker : Carolyn Troiano
    • Session Code : CTFEB0124
    • Date : 01st February 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins



Companies engaged in human clinical trials must comply with specific regulatory requirements. This includes maintaining a Trial Master File (TMF), which stores essential documents, content, and images related to the trial. The TMF is crucial as it contains all documentation needed to demonstrate a sponsor's adherence to their obligations in conducting a clinical trial.


According to the Code of Federal Regulations (21 CFR 312.50), sponsors are responsible for ensuring that investigations are conducted following the general investigational plan and protocols in the Investigational New Drug (IND) application. Similarly, the European Directive 2005/28/EC mandates that the TMF should consist of essential documents, allowing both the conduct of the clinical trial and the evaluation of the data quality.


The International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Section 8.1 describes these 'essential documents' as those that permit evaluation of the trial's conduct and the data produced. In 1996, the ICH published a consolidated guidance for industry on GCP, aiming to provide a unified standard for the United States, European Union, and Japan, thus facilitating mutual acceptance of clinical data by regulatory authorities in these jurisdictions.


While the US FDA does not specifically require a TMF, adherence to ICH GCP, which is often a regulatory requirement, implicitly necessitates creating and maintaining a TMF. These documents must be readily available for inspection by regulatory authorities during and after the trial and support product approval requests for pharmaceuticals, biologics, and medical devices.


The FDA's recent draft guidance on electronic records and signatures (March 2023) offers insights into the use of electronic systems, records, and signatures in clinical investigations. This guidance revises the June 2017 draft and, upon finalization, will supersede the May 2007 guidance on Computerized Systems Used in Clinical Investigations. It details the requirements under which the FDA considers electronic systems, records, and signatures as trustworthy and equivalent to paper records. While providing clarification, it introduces no new industry requirements and represents the FDA’s current stance on the subject.


Areas Covered during the session:


  • GxP Data and Computer Systems Regulated by FDA
  • Computer System Validation (CSV)
  • The System Development Life Cycle (SDLC) Methodology
  • Risk Assessment
  • GAMP®5 Software Categorization
  • Validation Strategy and Planning
  • Functional Requirements Specification (FRS)
  • Design/Configuration Specifications
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • System Acceptance and Notification of Release into Production
  • Maintenance and Operational Support of FDA-Regulated Computer Systems
  • Policies and Procedures to Support CSV
  • Training and Organizational Change Management (OCM) Supporting CSV Activities
  • Trial Master File (TMF) background and rationale
  • The essential documents to include in a TMF
  • Organizing and maintaining a TMF
  • Standard Operating Procedure required to support TMF
  • Inspection of TMF records
  • Electronic TMF (eTMF)


Why should you attend?


Navigating the complexities of FDA regulations for clinical trials and data systems is a critical challenge facing professionals in the pharmaceutical, biotech, and medical device industries. This webinar is an essential guide to mastering the key areas of GxP Data, Computer System Validation (CSV), and the System Development Life Cycle (SDLC), which are pivotal in ensuring compliance with FDA standards.


Are you fully prepared to implement and maintain a Trial Master File (TMF) that meets the stringent requirements of the FDA? Do you understand how to effectively categorize software under GAMP®5 and develop a robust validation strategy? This webinar will provide you with the expertise to confidently address these questions.


You’ll gain insights into creating detailed Functional Requirements Specifications, ensuring your installation, operational, and performance qualifications are conducted flawlessly, and maintaining FDA-regulated computer systems with precision. We’ll also delve into the recent draft guidance from the FDA on electronic records and signatures, a critical aspect for anyone involved in clinical investigations.


Whether you’re in charge of validating computer systems, managing clinical data, or ensuring regulatory compliance, this webinar will equip you with the essential knowledge and skills to excel in your role. Attend to stay ahead in the demanding field of FDA-regulated clinical trials and data management.


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 (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?


Personnel in the following roles 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 21 CFR Part 11, Clinical Trials Compliance, CSV and SDLC, TMF Guidelines, GxP Data, Regulatory Webinar, Electronic Recordkeeping, Compliance Training 2024, FDA Regulatory Standards, Clinical Research Management, February 2024, Carolyn, Troiano