Computer Systems Validation (CSV)

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, and image files, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Areas Covered in the Session : 

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Understand how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• The purpose and content of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
• Comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
• Learn appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
• Become aware of best-practices and inspector expectations for computer system validation and software quality assurance (SQA) programs
• 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
• 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 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
• Interactive Q&A Session

Seminar Agenda:

Day 1:

Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology

• FDA Compliance and Guidance
• Other Regulations and Guidance (EMA, EU, MHRA)
• Exercise: Exploring the Regulations using the fda.gov website
  

Module 2: CSV Methods and Models

• GxP Systems
• Computer System Validation (CSV)
• Validation, Verification, and Qualification
• Common SDLC Methodologies
• GAMP 5 “V” Model

Module 3: Software and Services

• Computer Off-the-Shelf (COTS) Software
• Cloud Systems
• FDA’s “Case for Quality”
• Software as a Service (SaaS)
• Case Study: Cloud SaaS
• Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
• Single Sign On (SSO)
• Medical Devices and Software as a Medical Device (SaaMD)
• Software Quality Assurance (SQA) Plan
• Mobile Devices and Medical Application
• Spreadsheet Validation

Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES

• 21 CFR Part 11 Guidance
• Electronic Records/Signatures (ER/ES) Requirements
• Exercise: FDA Guidance for ER/ES
• Vendor Audit
  

Module 5: Data Integrity and Governance

• Data Life Cycle Approach
• Data Integrity
• Data Governance

Day 2:

Module 6: CSV Planning

• Validation Strategy Document (VSD)
• Validation Strategy Components
• Rationale for Validation Testing
• GAMP 5 System Categorization
• Module 7: CSV Supporting Components
• Good Documentation Practices (GDPs)
• Training
• Organizational Change Management (OCM)
• CSV Policies and Procedures

Module 8: Risk-Based CSV

• Risk Assessment
• Risk Mitigation
• Exercise: Validation Master Plan (VMP) Writing

Module 9: System Requirements and Design

• Requirements Development
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Exercise: Interviews and URS/FRS Writing
• System Design/Configuration Management Specification
• (SDS/CMS)

Module 10: IQ, OQ, PQ Test Planning and Execution

• IQ, OQ, PQ Purpose and Contents
• CSV Test Execution
• Exercise: IQ, OQ, PQ Test Protocol Writing
• CSV Test Summary Report

Day 3:

Module 11: Requirements Traceability Matrix (RTM)

• RTM Purpose and Contents
• Exercise: RTM Writing

Module 12: Test and Validation Reports

• Validation Summary Report (VSR) Purpose and Contents
• System Acceptance and Release Notification

Module 13: Change Management

• Maintaining Validation Status
• Change Control Process
• Security and Access
• Audit Trail Review
• Incident Reporting
• Periodic System Review
• Disaster Recovery Planning
• Business Continuity Planning

Module 14: System Retirement

• Record Retention
• System Retirement Challenges
• Legacy Systems and Integration
• Data Migration

Module 15: FDA Warning Letters

• Regulatory Influences
• Regulatory Trends
• Critical Thinking
• Current Compliance and Enforcement Trends
• FDA Inspection Readiness
• Exercise: Be the Consultant
• Industry Best Practices

Who Should Attend:

IT, QA, & Business Managers and Professionals who need to:

• Manage or participate on computer system projects requiring validation
• Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
• Understand the process of computer system validation
• Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
• Understand the FDA and international regulatory landscape around CSV

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
• 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.

Course Director: CAROLYN TROIANO ‎

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. 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. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.