Computer Systems Validation 3-Day Boot Camp – April 27-29, 2022 –

DUBLIN–(BUSINESS WIRE)–Computer System Validation (CSV) Boot Camp training has been added to from offer.

Validation of computer systems has been regulated by the FDA for more than 30 years as it pertains to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other industries. regulated by the FDA. FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze, and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by the FDA in 1997 and disseminated through 21 CFR Part 11. This code outlines the basic requirements for validating and documenting the ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, the FDA recognized that it could not inspect all computer systems of all regulated companies and gave industry the responsibility to begin assessing all regulated computer systems for risk. The level of potential risk, should the system not function properly, should form the basis of each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key elements in determining the scope and robustness of the tests required to ensure data integrity and product security.

The FDA’s recent emphasis on data integrity during inspections and validation audits of computer systems has brought this issue to the forefront of compliance importance for systems used in regulated industries. These include all systems that “touch” the product, meaning they are used to create, collect, analyze, manage, transfer, and report FDA-regulated data. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations and image files, audio and video files, among others, should be managed and maintained with integrity throughout their life cycle.

This bootcamp will explore best practices and the strategic approach to evaluating IT systems used in the conduct of FDA-regulated activities and determining the level of potential risk, in the event of failure, to data integrity, data quality, processes and products, and consumer/patient safety. He will review the system development life cycle (SDLC) validation approach, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing records and electronic signatures appropriately.

The course will also review all essential policies and procedures, as well as other supporting documents and activities that must be developed and followed to ensure compliance. It will provide an overview of practices for preparing for an FDA inspection and will also discuss the importance of auditing vendors of computer hardware, software, tools and utilities, and services.

Finally, it will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to help you in all your GxP work.

Main topics covered:

  • Learn to identify “GxP” systems

  • Discuss Computer System Validation (CSV) approach based on FDA requirements

  • Learn more about the System Development Life Cycle (SDLC) approach to validation

  • Understand how to comply with key FDA regulations and guidelines and international CSV standards, such as 21 CFR Part 11 and Annex 11

  • The purpose and content of each validation deliverable, including validation plan, requirements specification, test plan, validation tests (IQ, OQ, PQ), requirements traceability matrix, summary tests and the validation report, etc.

  • Understand risk-based validation techniques and how to leverage these techniques to create effective yet compliant validation approaches

  • Learn the appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom-built systems

  • Learn about best practices and inspector expectations for computer systems validation and software quality assurance (SQA) programs

  • Discuss best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures

  • Understand how to maintain a system in a validated state throughout the system lifecycle

  • Learn how to ensure data integrity that supports GxP work

  • Discuss the importance of FDA-compliant “GxP” documentation

  • – Learn about the policies and procedures needed to support your validation process and the ongoing maintenance of your systems in a validated state

  • Understand the key elements of 21 CFR Part 11 compliance for electronic records and signatures

  • Know the regulatory influences driving current FDA thinking at any given time

  • Learn how to conduct a risk assessment on IT systems that will serve as the basis for the development of a validation rationale

  • Understand the need to include an assessment of the size, complexity, business criticality, GAMP 5 category and risk of an IT system, in the event of failure, in order to develop a consistent validation rationale and complete

  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system

  • Understand the importance of conducting a thorough vendor audit to ensure oversight of the products and services they provide

  • Finally, understand industry best practices that will allow you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the lifecycle. data life.

  • Interactive Q&A session

For more information on this training visit

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