Common Problems in Validation of FDA-Regulated Computer Systems

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Mar 29, 2018
60 minutes
Product Description

Understand the Phases within the SDLC and the Sequence of Steps for FDA-Compliant CSV

Applying the system development life cycle (SDLC) methodology when validating computer systems subject to FDA regulations 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.

Join this session, where expert speaker Carolyn Troiano will help you understand in detail computer system validation (CSV) and how to apply the SDLC methodology when validating computer systems subject to FDA regulations. Carolyn will discuss the phases within the SDLC, and how they form the basis for any CSV project. This session will cover the importance of the sequence of steps.

The session will focus on the most common issues and problems that arise when trying to complete a validation effort. Generally, these are the result of not having planned the validation properly, not executing it accurately and completely, and not having the necessary procedures and processes in place to support the work. The session will describe the most common issues, and it will be clear why these are often overlooked by companies when doing validation work.

Session Objectives

This session will discuss:

  • The most common issues and problems that arise when validating an FDA-regulated computer system
  • Industry best practices related to compliance and computer system validation
  • Strategies for reducing the cost and complexity of compliance with FDA regulations
  • How the SDLC methodology supports the computer system validation process
  • How to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, thus, minimizing both
  • How to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
  • How to gain information about trends in validation, as industry progresses and new best practices emerge

Session Highlights

This session will cover:

  • 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 link design to functional requirements
  • 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 archival to ensure security, integrity and compliance
  • Maintaining a system in a validated state

Who Should Attend

  • Information technology analysts
  • QC/QA managers
  • QC/QA analysts
  • Clinical data managers
  • Clinical data scientists
  • Analytical chemists
  • Compliance managers
  • Laboratory managers
  • Automation analysts
  • 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

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Carolyn Troiano - FDA Regulation Expert

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn has spent a number of years evaluating supply chain security and compliance, including technologies...   More Info
More Events By The Speaker

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