Computer System Validation (CSV) vs. Computer System Assurance (CSA)

Learning Objectives

• To discuss how to identify “GxP” systems.
• To inspect FDA’s current thinking about technology and software development, and how this will impact the industry.
• To discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements.
• To analyze 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.
• To explain the pros and cons of an Agile vs. Waterfall approach.
• To analyze cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively.
• To discuss 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.
• To analyze 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.
• To investigate how to assure the integrity of data that supports GxP work, despite changes and advances in new technology.
• To inspect the importance of “GxP” documentation that complies with FDA requirements.
• To discuss the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.
• To analyze the regulatory influences that lead to FDA’s current thinking at any given time
• To discuss 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.

Course Description

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by 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 greatly 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 approaches.

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 specifically addressing the risk of potential failure of each requirement.

GAMP5 supports the use of incremental, iterative, and evolutionary approaches including Agile, for the development of 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 Information Technology CPE webinar, the speaker Carolyn Troiano will help you to align the agile methodology to the GAMP5 “V” model and system development life cycle (SDLC) methodology.

Overview

• FDA regulatory oversight

  3 mins
• Computer system validation (CSV)

  8 mins
• 21 CFR part 11 Compliance

  33 mins
• CSV vs. Computer software assurance (CSA)

  42 mins
• Waterfall vs. Agile methodology

  57 mins
• Cloud services & Software as a service

  67 mins