In Depth Testing of Computer Systems Regulated by FDA

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jan 23, 2018
60 minutes
Product Description

Testing and Maintaining the System under FDA’s Computer Systems Validation Requirements

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. 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 must follow best practices for developing a validation program that includes planning, execution and maintenance components to ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience. Join this session with expert speaker Carolyn Troiano to learn all about preparing your system validation documentation for an FDA audit of your company’s computer systems.

One of the most critical aspects of validation is the testing phase, which includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). A protocol must be prepared and followed for each one, along with a summary report. These activities will ensure the system is properly installed, and that not only does the core functionality work, but it works in the way the user will challenge it during day-to-day operations.

You will learn about the testing component of computer system validation (CSV) work that’s aligned with the system development life cycle (SDLC) methodology, which includes:

  • Determining the category of your system, based on GAMP 5 from ISPE
  • Determining the risks associated with the various ways your system may fail
  • Using the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted

Session Objectives

This session will help you understand:

  • The testing component of computer system validation (CSV) work that is aligned with the system development life cycle (SDLC) methodology, which includes:
    • Determining the category of your system, based on GAMP 5 from ISPE
    • Determining the risks associated with the various ways your system may fail
    • Developing a rationale for the level of testing, using the category and risk, to assure your system is thoroughly vetted
  • The FDA requirements for documentation of all testing activities
  • How to write a test protocol for each phase of testing, i.e. IQ, OQ, and PQ)
  • How to develop test scripts and acceptance criteria
  • How to identify test discrepancies and distinguish the type: test script errors, tester errors, and system errors
  • How to document all testing and the summary reports
  • How to maintain the system in a validated state, and keep testing as a ‘living’ exercise that runs through the system life cycle

Session Highlights

  • Computer system validation (CSV) and the system development life cycle (SDLC) methodology
  • Good “variable” practice (GxP) (good manufacturing practice, good laboratory practice, and good clinical practice)
  • Validation strategy that will take into account the system risk assessment process and GAMP 5 system categorization to analyze the best approach to testing
  • Functional requirements specification (FRS) to include detailed needs that are described in a specific and unique way, and include only those that you are going to use to minimize testing requirements
  • 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
  • Ongoing validation maintenance and governance
  • System retirement steps to close out the life cycle

Session Agenda

  • Definition and examples of GxP systems
  • Key premises of the FDA regulatory oversight
  • Definition and key takeaways of CSV
  • Key elements of SDLC
  • Risk assessment to plan and execute testing
  • Software categorization: Specific criteria and rationale
  • IQ/OQ/PQ and testing
  • GAMP 5 “V” model
  • Use of vendors and contractors
  • Validation plan and test plan requirements
  • Testing protocol and examples
  • Handling result deviations
  • Test documentation requirements
  • Requirements traceability matrix (RTM)
  • Preparing a testing summary report
  • System acceptance and notification
  • Standard operating procedures and templates
  • Training
  • Conducting periodic reviews

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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