Computer System Validation (CSV) vs. Computer System Assurance (CSA): Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer System
Master A Risk-based, Product Quality, and Patient-Centric Approach to Computer System Assurance (CSA)!
Instructor :
Carolyn Troiano
Webinar ID:
4598
Date: NOV 28, 2024 (THU)
Start Time: 10 am PT
Duration: 90 Mins.
What you will learn
- FDA’s current thinking about technology and software development, and how this will impact industry
- Current state of Computer System Validation (CSV) approach based on FDA requirements
- The System Development Life Cycle (SDLC) approach to validation
- FDA’s current thinking about technology and software development, and how this will impact industry
- Current state of Computer System Validation (CSV) approach based on FDA requirements
- The System Development Life Cycle (SDLC) approach to validation
- More agile approach: automated testing for continuous validation
- Pros and cons of an agile vs. waterfall approach
- Cloud computing and SaaS systems that can be embraced and validated effectively
- Best practices for documenting computer system validation efforts
- How to assure the integrity of data that supports GxP work and so much more…
Course Description
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices.
There has also been a lower than anticipated investment in automation and digital technologies, which could significantly improve quality and process control.
A key element is a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach.
This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven practices.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without explicitly addressing the risk of potential failure of each requirement.
GAMP5 supports the use of incremental, iterative, and evolutionary approaches, including agile, to develop custom applications.
Keys to success include a robust Quality Management System and well-trained and highly disciplined teams following well-defined processes supported by tools and automation.
In this interactive webinar, participants will learn:
- How to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
- This approach is amenable to the agile software development methodology, which can be adapted for validation.
- We will also discuss the critical aspects of CSV and how to apply them in a new and modern technological environment.
Join Now!
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices.
There has also been a lower than anticipated investment in automation and digital technologies, which could significantly improve quality and process control.
A key element is a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach.
This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven practices.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without explicitly addressing the risk of potential failure of each requirement.
GAMP5 supports the use of incremental, iterative, and evolutionary approaches, including agile, to develop custom applications.
Keys to success include a robust Quality Management System and well-trained and highly disciplined teams following well-defined processes supported by tools and automation.
In this interactive webinar, participants will learn:
- How to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
- This approach is amenable to the agile software development methodology, which can be adapted for validation.
- We will also discuss the critical aspects of CSV and how to apply them in a new and modern technological environment.
Join Now!
Why you should attend
Advancements in technology have forced organizations to rethink business models!
Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers who are better informed and have higher expectations than ever before. As a result, work practices and tools must change to meet these challenges.
The approach to developing software, performing validation, and maintaining a system in a validated state through its entire life cycle should be carefully considered to meet changing needs.
This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each.
There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
Enroll Now!
Advancements in technology have forced organizations to rethink business models!
Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers who are better informed and have higher expectations than ever before. As a result, work practices and tools must change to meet these challenges.
The approach to developing software, performing validation, and maintaining a system in a validated state through its entire life cycle should be carefully considered to meet changing needs.
This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each.
There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
Enroll Now!
Areas Covered
- Learn how to identify “GxP” Systems
- Learn about FDA’s current thinking about technology and software development, and how this will impact industry
- Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
- Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
- Learn the pros and cons of an agile vs. waterfall approach
- Learn about cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
- Understand the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
- Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an agile continuous validation approach
- Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
- Understand the importance of “GxP” documentation that complies with FDA requirements
- 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
- 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
- Learn about FDA’s current thinking about technology and software development, and how this will impact industry
- Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
- Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
- Learn the pros and cons of an agile vs. waterfall approach
- Learn about cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
- Understand the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
- Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an agile continuous validation approach
- Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
- Understand the importance of “GxP” documentation that complies with FDA requirements
- 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
- 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
Who is this course for
- 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
Instructor Profile
Carolyn Troiano has more than 40 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.
