FDA Software Validation and Verification, Computer System Validation: Step-by-Step

Product Id : FDA65
Instructor : Carolyn Troiano
Nov 20, 2017 12:15 PM ET | 11:15 AM CT | 09:15 AM PT | 60 Minutes

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Overview

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best practices for meeting these requirements isn't always clear. Your software may be compliant, but you may not be. This webinar provides you answers  to the  top most Six common software validation and documentation questions asked by the others in FDA regulated industries and express the  best practices for meeting the instruction.

The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated. While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they have to need  that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a best result of assurance that a specific process will always  generate the expected result or output of the given input.

Documentation is required for Regulatory Validation:

  • Software Validation Protocol (Validation Plan)
  • System /Software Requirements Specification
  • Network Diagram
  • Risk Analysis
  • 21 CFR Part 11 Compliance Analysis
  • Design Specification
  • Verification Protocol (Test Plan)
  • Test Specifications (Test Cases)
  • Requirements Traceability Matrix
  • Final Validation Report

Session Highlights :

  • Computer System Validation (CSV)
  • 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
  • User Requirements Specification (URS) to include high-level needs in language familiar to the user
  • 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 (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) (also referred to as User Acceptance Testing (UAT))
  • Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
  • System Acceptance by the user or owner of the system
  • System Release Notification once it is put into a production environment
  • System Retirement steps to close out the life cycle
  • Data Archival to ensure security, integrity and compliance

Who Will Benefit:

  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Automation Analysts
  • GMP Training Specialists
  • All FDA-regulated industries: Pharmaceutical, Biologicals, Medical Device, Tobacco, Animal Health


Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).


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