Computer System Validation Training Boot Camp®

Course Description

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 seminar 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.

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
• 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)

Day 1 Q&A Session

Day 2

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 

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

Day 3

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 3 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

Who will benefit from this CSV Course

• 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