Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology

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.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile, for 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.

Why Should You Attend:

The attendee will learn about 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 will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.

Areas Covered in the Webinar:

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Understand the agile methodology and comparison to the waterfall approach
• Understand Computer Software Assurance (CSA) and the use and value of automated testing and critical thinking
• Learn about the System Development Life Cycle (SDLC) approach to validation
• 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
• Discuss 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
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Understand the requirements for data integrity - the ALCOA Plus principles
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
• 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
• Learn how to assess risk, based on probability of occurrence, severity of impact, detectability and mitigation, along with technical and procedural controls that can help minimize risk
• 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

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.