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.
Areas Covered
- Learn how to identify “GxP” Systems
- Learn about FDA’s current thinking about technology and software development, and how this will impact industry
- Discuss the current state of 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 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 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 assure 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
- 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
Agenda
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
- FDA’s “Case for Quality”
- Cloud Systems
- Software as a Service (SaaS)
- Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
- Single Sign On (SSO)
- Medical Devices and Software as a Medical Device (SaaMD)
- Mobile Devices and Medical Application
- Spreadsheet Validation
Module 3: CSV Planning
- Validation Strategy Document (VSD)
- Validation Strategy Components
- Rationale for Validation Testing
- GAMP®5 System Categorization
- Risk Assessment
- Risk Mitigation
- Exercise: Risk Assessment
Module 4: System Requirements and Design
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- System Design/Configuration Management Specification (SDS/CMS)
- Exercise: Application and Design
Day 2:
Module 5: IQ, OQ, PQ Test Planning & Execution
- IQ, OQ, PQ Purpose and Contents
- CSV Test Execution
- CSV Test Summary Report
Module 6: Test and Validation Reports
- Requirements Traceability Matrix (RTM) Purpose and Contents
- Validation Summary Report (VSR) Purpose and Contents
- System Acceptance and Release Notification
Module 7: CSV Operations and Maintenance
- Maintaining a System in a Validated State
- Disaster Recovery Planning
- Business Continuity Planning
- Record Retention
- System Retirement Challenges
- Legacy Systems and Integration
- Data Migration
Module 8: CSV Supporting Components
- Good Documentation Practices (GDPs)
- Training
- Organizational Change Management (OCM)
- CSV Policies and Procedures
Day 3:
Module 9: Managing FDA-Regulated Data
- 21 CFR Part 11 Guidance
- Electronic Records/Signatures (ER/ES) Requirements
- Data Life Cycle Approach
- Data Integrity
- Data Governance
Module 10: Vendor Audit
- Audit Preparation
- Audit Execution
- Post-Audit
Module 11: FDA Trends
- Regulatory Influences
- Regulatory Trends
- Current Compliance and Enforcement Trends
Module 12: Inspection Preparation
- FDA Inspection Readiness
- Industry Best Practices
Module 13 CSV Exercises
- Exercise 1: CSV
- Exercise 2: Validation Master Plan (VMP) Writing
- Exercise 3: FDA Requirements for ER/ES
- Exercise 4: Interviews and URS/FRS Writing
- Exercise 5: IQ, OQ, PQ Test Protocol Writing
- Exercise 6: RTM Writing
- Exercise 7: Be the Consultant
Course Provider
Carolyn (McKillop) Troiano,
IT Program Manager and FDA Compliance Consultant ,
Smart Resources, Inc.Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Who Should Attend
- 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
