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 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 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, so it is essential to understand what must be considered when determining.

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.

Day 1:

Module 1: CSV Methods and Models

•       GxP Systems
•       Computer System Validation (CSV)
•       Common SDLC Methodologies
•       GAMP®5 “V” Model
•       Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
•       Critical Thinking
•       Waterfall vs. Agile Methodology

Module 2: Software and Services

•       Computer Off-the-Shelf (COTS) Software
•       Cloud Systems
•       Software as a Service (SaaS)
•       Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
•       Single Sign On (SSO)
•       Medical Devices using Software.
•       Software-as-a-Medical Device (SaaMD)
•       Mobile Devices
•       Spreadsheet Validation

Module 3: CSV Planning

•       Validation Plan
•       Rationale for Validation Testing
•       GAMP®5 System Categorization
•       Risk Assessment and Mitigation

Module 4: System Requirements and Design

• Requirements Development
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• System Design/Configuration Management Specification (SDS/CMS)

Module 5: IQ, OQ, PQ Test Planning & Execution

•       Validation Protocols - IQ, OQ, PQ
•       Validation Test Execution
•       Validation Test Summary Report

Module 6: Test and Validation Reports

• Requirements Traceability Matrix (RTM)
• Validation Summary Report
• System Acceptance and Release Notification 

Day 1 Q&A Session

Day 2:

Module 7: CSV Operations and Maintenance

• Maintaining a System in a Validated State
• Disaster Recovery Planning
• Business Continuity Planning
• Incident Reporting, Investigation, and Remediation
• Record Retention
• System Retirement Challenges
• Legacy Systems and Integration
• Spreadsheet Validation

Module 8: CSV Supporting Components

• Good Documentation Practices (GDPs)
• Training
• Organizational Change Management (OCM)
• Validation Policies and Procedures

Module 9: Managing FDA-Regulated Data

•   21 CFR Part 11 Guidance
•   Electronic Records/Signatures (ER/ES) Requirements
•   Data Integrity: ALCOA+ Principles
•   Data Life Cycle Approach
•   Data Governance
•   Data Privacy: HIPAA, GDPRs, et al

Module 10: Vendor Audit

• Audit Preparation
• Audit Execution
• Post-Audit
• Vendor Contracts and Service Level Agreements (SLAs)

Module 11: FDA Trends

• Regulatory Influences
• Regulatory Trends
• Current Compliance and Enforcement Trends

Module 12: Inspection Preparation

FDA Inspection Readiness

Industry Best Practices

Day 2 Q&A Session

Module 13: CSV Exercises

•  Exercise 1: CSV
•  Exercise 2: Validation Plan (VMP) Writing
•  Exercise 3: Risk Assessment
•  Exercise 4: FDA Requirements for ER/ES
•  Exercise 5: Interviews and URS/FRS Writing
•  Exercise 6: IQ, OQ, PQ Test Protocol Writing
•  Exercise 7: RTM Writing
•  Exercise 8: Be the Consultant

Why should you attend

The attendees will learn about how to take advantage of modern, evolving technology while remaining compliant with FDA regulations related to computer systems and data. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying the FDA’s draft guidance for Computer Software Assurance (CSA) using an agile approach, including automated testing tools that will result in a continuous validation of software products. The CSA approach is risk-based and relies heavily on critical thinking. It is aligned with GAMP®5, Second Edition, published in July 2022. We will discuss the pros and cons of various approaches and industry best practices for success.

The attendee will learn to validate systems to meet 21 CFR Part 11 and data integrity compliance. We will touch on compliance with data privacy laws, including HIPAA, GDPRs, and other privacy regulations.

We will 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.

We will also address spreadsheet validation. Tools time, tools like MS Excel, Google Sheets, and others do not have to be validate of the boxt-of-the-box without any customization. However, if you include macros or any customization, it must be validated. Learn about a streamlined approach to get a handle on the plethora of spreadsheets used across your organization for FDA-regulated data.

This in-person seminar will provide ample time for more significant audience interaction. Bring your most pressing questions, describe ryour “pain points,” and learn how to solve some of the most confounding validation-related issues.

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• 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
• Vendors responsible for software development, testing, and maintenance
•  Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance.

Areas Covered

• Learn how to identify “GxP” Systems.
• Learn about the FDA’s current thinking about technology and software development and how this will impact the industry.
• Discuss the current state of the 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 about cloud services and cloud service providers to optimize your experience.
• Learn ways to validate in the cloud without compromising quality or compliance.
• Learn the pros and cons of an agile vs. waterfall approach
• We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
• 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 the efficiency and effectiveness of managing related documentation
• Understand the best approach to Installation Qualification (IQ) testing when the system components are not on-premise but are in the cloud
• 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 ensure the integrity of data that supports GxP work despite changes and advances in new technology
• 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
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn about current trends in FDA compliance and enforcement
•  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