• Functional and System Requirements for Systems Regulated by FDA - New Updates Included
  • Functional and System Requirements for Systems Regulated by FDA - New Updates Included

    • Speaker : Carolyn Troiano
    • Session Code : CTJUN2823
    • Date : 28th June 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins



Computer System Validation (CSV) has been regulated by FDA for more than 35 years, as it relates to systems used in the manufacture, testing, distribution, and management of a product in the pharmaceutical, biotechnology, medical device, tobacco, and related industries. The requirements phase of the CSV process is a key aspect of validating a system by providing the functions and features the user will require to perform their operations.


The course will focus on the key aspects of requirements development and management, including best practices and principles for handling this key component of project work in an FDA-regulated environment (i.e., the system “touches” product during the manufacturing, testing or distribution of the product, or during any other functional activity).  The material will include the various aspects of how to develop requirements, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance.  It will also provide guidance on how to keep costs low and avoid “scope creep,” which can lengthen the time and require more money to achieve.


Requirements include both functional and non-functional, or system requirements. We’ll describe the differences and elaborate on the key characteristics of a good written requirement. The approach includes determining risk at the requirement level, providing a risk rating for each that can be used to determine the type and level of testing required.


Requirements at a high level should be documented using business terminology to describe the intended use of the system. The high-level requirements are then used as a basis for developing the unique functional requirements and non-functional, or system requirements. Requirements will be mapped to the one or more test script(s) that will be executed to prove the requirement is met.


Learn about the best practices for preparing detailed requirements during CSV, including the acceptance criteria that must be met to assure the requirement is proven through testing.


We will also cover Computer Software Assurance (CSA), the draft guidance issued by FDA in September 2022. CSA provides a pathway for streamlining the validation process, focusing on areas of functionality that could potentially cause risk, if they failed to be met. Using a risk-based approach, the attendee can learn the best practices for creating and executing against a specific risk methodology.


CSA also includes automated testing and critical thinking, each of which we will touch upon during the session. Note that GAMP®5, Second Edition was issued in July 2022, and we will talk about how it aligns with the concepts behind CSA. Both GAMP®5, Second Edition and CSA align with an agile methodology for software development and testing. We’ll show you how the GAMP®5 “V” Model can be aligned with agile, as well.


Areas Covered in the Session:

  • Learn the characteristics of well-written requirements
  • Learn where to gather information and who to speak with when preparing a requirements specification
  • Understand the importance of clearly written, well-defined requirement definition
  • Understand how the requirements will set the tone for CSV testing
  • Learn about the Requirements Traceability Matrix (RTM) that links every requirement with one or more test scripts that support it
  • Learn how to rate the potential risk of a requirement failing and how this influences testing during CSV
  • Identify functional vs. non-functional, or system requirements
  • Understand the approach for software development following GAMP®5, Second Edition and FDA’s draft guidance for Computer Software Assurance (CSA); these two are very aligned
  • Learn how to capture the requirements electronically
  • Q&A


Why Should You Attend?


You should attend this webinar if you are part of a team developing requirements for a system that is regulated by FDA. This is for a new system or an update to an existing system where functionality might be changed. Typically, Subject Matter Experts (SMEs) who understand the business process and can map it to specific functional requirements.


Note that system, or non-functional requirements are the “enablers” of functionality and must be present for the functionality to be delivered. This should also be attended by the technical resources who understand the system needs.


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?


  • 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, Functional Requirements, System Requirements, Regulatory Compliance, Medical Device, Pharmaceutical, FDA Webinar, Dayna Reum, June 2023,