Implementing the Computer Software Assurance (CSA): A Risk-based approach

Transitioning to the new guidance will require unlearning “the old” and relearning how to apply Computer Software Assurance (CSA). The emphasis is on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Even though this guidance is being developed for the medical device industry, the FDA has indicated it should be considered when deploying non-product, manufacturing, operations, and quality system software solutions, such as quality management systems (QMS), enterprise resource planning (ERP) systems, laboratory information management systems (LIMS), learning management systems (LMS), and electronic document management systems (eDMS). As such, the guidance will apply to research and development (R&D), clinical, laboratory, and other groups within pharmaceutical, biopharmaceutical, and medical device companies that are currently meeting the regulations for electronic records and electronic signatures (ERES) and computer system validation (CSV).

Why should you attend

This training will give you a foundation for understanding the guidance, if (and how) it is right for you, and steps to practically assess benefits and apply the guidance. This session will provide definitions of critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Also, it will focus on how to transition from CSV to CSA, leveraging CSV methodology, business processes, and risk management.

In addition, the FDA believes that applying a risk-based approach to computer software used as part of medical device production or the quality system would better focus manufacturers’ assurance activities to help ensure product quality while helping to fulfill the validation requirements of 21 CFR?820.70(i).

Who should attend

This course will be of benefit to anyone working in a regulated environment who is part of the team that performs, reviews, and approves Manufacturing, Operations, and Quality Systems Software, as well as non-product manufacturing, operations, and quality system software solutions. This includes personnel in:

• Clinical Operations
• Engineering & Maintenance
• Information Technology
• Legal Counsel
• Manufacturing & Operation
• Supply Chain; logistic & Distribution
• Quality & Validation
• Regulatory Affairs

Learning objectives

After this session, you will be able to:

• Explain the differences between CSV and CSA, and the short- and long-term benefits of moving to CSA
• Define and discuss key terms and concepts being introduced with CSA, including critical thinking and risk management
• Define and discuss patient and product safety, data integrity, and quality assurance
• Identify, categorize, and classify a system’s intended use and classify software failure risks
• Build foundational knowledge required to transition from CSV to CSA
• Provide an approach to plan for CSA transition to include people, process, technology,y and product
• Develop quality metrics (qualitative and quantitative) on organizational performance: people, process, project,t and technology
• Create a Transition Plan – with a phased road map for a successful transition to CSA
• Maintain the system in a validated state 

Education approach

• Lecture sessions are illustrated with examples based on case studies
• Practical exercises include examples and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer