Functional System Requirements for Computer Systems Regulated by FDA

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    Speaker: Carolyn Troiano

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    Duration: 90 Minutes
    Product Code: 50749
    Level: Intermediate


This webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV), focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance.

This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process.


You should attend this webinar to learn about:

  • Computer System Validation (CSV) approach.
  • Using the System Development Life Cycle (SDLC) methodology to support CSV efforts.
  • CSV and SDLC deliverables that must be documented properly to comply with FDA requirements.
  • A deeper dive into the Functional Requirements Specification (FRS) deliverable, a key document to support the CSV effort.
  • Policies, procedures, training, and organizational change management that are all key aspects of a successful CSV effort and developing detailed and thorough requirements.
  • Industry best practices related to CSV and the SDLC methodology, as well as for delivering solid requirements.
  • Common findings of FDA related to CSV during computer system inspection and audit that can be avoided by following best practices to develop solid requirements as part of the effort.


  • Requirements for Computer System Validation (CSV) in compliance with FDA.
  • Applying a strategic approach to CSV for FDA compliance.
  • Using the System Development Life Cycle (SDLC) methodology to support CSV.
  • CSV strategic planning, execution, and documentation.
  • Detailed analysis of the Functional Requirements Specification (FRS), a key deliverable for the CSV effort.
  • Policies and procedures to support the CSV effort and your requirements.
  • Training and organizational change management best practices to support CSV and development of detailed and thorough requirements for testing.
  • Preparing your computer system documentation for an FDA inspection.
  • Q&A


  • We will provide an overview of FDA’s guidelines as they pertain to computer system validation of GxP systems used in manufacturing, marketing, distribution and other operational activities engaged by companies in FDA-regulated industries.
  • We will describe the System Development Life Cycle (SDLC) methodology and how to apply it to Computer System Validation (CSV) work.
  • We will review the SDLC deliverables key to a successful CSV effort.
  • We will take a deeper dive into the Functional Requirements Specification (FRS) process and documentation to support a successful CSV effort.
  • This course will describe the best practices for developing detailed and thorough FDA system validation requirements, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.
  • We will provide specific guidance on industry best practices for delivering solid requirements that will meet FDA compliance.


This webinar will provide valuable assistance to all personnel in:

  • Data “Owners”
  • Data “Stewards”
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Consultants working in the life sciences industry who are involved in the validation of computer systems.


Years of Experience: 35+ years

Areas of Expertise: Strategic Planning, Project Management, FDA Regulatory Compliance, Organizational Development & Effectiveness, and Change Leadership & Management

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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