Developing a Strategic Approach to FDA Compliance for Computer Systems

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    Speaker: Carolyn Troiano

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    Duration: 90 Minutes
    Product Code: 51061
    Level: Intermediate

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FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on System Development Life Cycle (SDLC) Methodologies.

The webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.  You will learn about what must be done to ensure the system remains in a validated state.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.


This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodologies when validating computer systems subject to FDA regulatory compliance. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.


•  Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
•  Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
•  Validation Strategy that will take into account the system risk assessment process
•  Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
•  System Design Specification (SDS) that details how the functional requirements will be delivered
•  Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
•  Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
•  System Acceptance and Release Notification
•  System Retirement steps to close out the life cycle
•  Data integrity to avoid FDA compliance deficiencies
•  Data Archival to ensure security, integrity and compliance


•  To understand how to create, revise and maintain documentation that must meet the FDA compliance standards
•  To understand the computer system validation documentation and many deliverables required to complete the effort
•  To understand industry best practices
•  To understand and avoid potential pitfalls


•  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

All FDA-regulated industries:
•  Pharmaceutical
•  Biologicals
•  Medical Device
•  Tobacco


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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