Three Day Virtual Computer System Validation for Cloud and COTS Applications Course, March 2-4, 2022
DUBLIN, Feb. 18, 2022 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications" training has been added to ResearchAndMarkets.com's offering.
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 that are better informed and with higher expectations than ever before. 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 in order 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.
We'll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we'll include the best practices for meeting FDA's requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA's current concerns and how to ensure your systems will meet their expectations.
Why Should You Attend
The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways 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 use in validation. We'll discuss the pros and cons of each approach, and industry best practices for success.
We'll cover Computer-Off-the-Shelf (COTS) software, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services. You'll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.
Module 1: CSV Methods and Models
Module 2: Software and Services
Module 3: CSV Planning
Module 4: System Requirements and Design
Module 5: IQ, OQ, PQ Test Planning & Execution
Module 6: Test and Validation Reports
Module 7: CSV Operations and Maintenance
Module 8: CSV Supporting Components
Day 3:Module 9: Managing FDA-Regulated Data
Module 10: Vendor Audit
Module 11: FDA Trends
Module 12: Inspection Preparation
Module 13 CSV Exercises
For more information about this training visit https://www.researchandmarkets.com/r/kv875y
Research and Markets
SOURCE Research and Markets