Instructor :
Carolyn Troiano

Webinar ID:
4601

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.

The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems that collect, analyze and/or report data.

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

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.

The level of potential risk, should the system fail to operate correctly, needed to be the basis for 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 5 critical components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of the importance for compliance of systems used in regulated industries.

These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.

In addition, all structured data, including databases, unstructured data, documents, spreadsheets, presentations, and image files, audio and video files, must be managed and maintained with integrity throughout their life cycle.

In this session, we will:

• Explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
• Walk through the System Development Life Cycle (SDLC) approach to validation based on risk assessment and will also discuss 21 CFR Part 11 and the importance of appropriately managing electronic records and signatures.
• Walk through the entire set of essential policies and procedures and other supporting documentation and activities that must be developed and followed to ensure compliance.
• Provide an overview of practices to prepare for an FDA inspection and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
• An overview of industry best practices, focusing on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

In this interactive webinar , the attendee will learn strategic ways to plan, execute, and document work from CSV activities based on the System Development Life Cycle (SDLC) approach.

We will also discuss the critical concepts of CSV and industry best practices and how to apply them in a new and modern technological environment.

Join Now!

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.

The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems that collect, analyze and/or report data.

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

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.

The level of potential risk, should the system fail to operate correctly, needed to be the basis for 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 5 critical components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of the importance for compliance of systems used in regulated industries.

These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.

In addition, all structured data, including databases, unstructured data, documents, spreadsheets, presentations, and image files, audio and video files, must be managed and maintained with integrity throughout their life cycle.

In this session, we will:

• Explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
• Walk through the System Development Life Cycle (SDLC) approach to validation based on risk assessment and will also discuss 21 CFR Part 11 and the importance of appropriately managing electronic records and signatures.
• Walk through the entire set of essential policies and procedures and other supporting documentation and activities that must be developed and followed to ensure compliance.
• Provide an overview of practices to prepare for an FDA inspection and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
• An overview of industry best practices, focusing on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

In this interactive webinar , the attendee will learn strategic ways to plan, execute, and document work from CSV activities based on the System Development Life Cycle (SDLC) approach.

We will also discuss the critical concepts of CSV and industry best practices and how to apply them in a new and modern technological environment.

Join Now!

Effective and compliant computer system validation is critical to any FDA-regulated organization.

During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.

In this interactive webinar, participants will learn the following:

• Guidance for planning
• Executing and validating a laboratory computer system, and
  managing the system in a validated state through the end of the system life cycle.
• The validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.

We will also cover the following:

• The actual validation phases
• Deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation,
• How to make sure the approach is cost-effective for your organization.
• Roles and responsibilities,
• Timing of phases and deliverables,
• Business process reengineering, organizational change management, change control, audit trails, training, and documentation.
• What is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer in use.

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.

• This is critical 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.

Enroll Now!

Effective and compliant computer system validation is critical to any FDA-regulated organization.

During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.

In this interactive webinar, participants will learn the following:

• Guidance for planning
• Executing and validating a laboratory computer system, and
  managing the system in a validated state through the end of the system life cycle.
• The validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.

We will also cover the following:

• The actual validation phases
• Deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation,
• How to make sure the approach is cost-effective for your organization.
• Roles and responsibilities,
• Timing of phases and deliverables,
• Business process reengineering, organizational change management, change control, audit trails, training, and documentation.
• What is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer in use.

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.

• This is critical 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.

Enroll Now!

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Understand how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• Learn the purpose and content of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
• Learn appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
• Discuss the 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 through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Understand how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• Learn the purpose and content of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
• Learn appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
• Discuss the 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 through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries