Syllabus
Computer Software Assurance and Computerized System Validation Professional Certificate
42 lessons, about 14 hours. Online and self-paced, with a certificate when you finish.
GxP Systems and Regulations
Establish the regulatory and technical foundations needed to identify regulated computerized systems, interpret applicable requirements, and distinguish binding obligations from regulatory and industry guidance.
- 1GxP Computerized System Fundamentals
- 2Regulatory Hierarchy and Applicable Standards
- 3Part 11 Electronic Records and Signatures
- 4Pharmaceutical and Laboratory System Controls
- 5Regulatory Applicability Matrix Development
- 6Clinical Investigation Electronic Systems and Records
System Scope and Risk
Teach learners to inventory computerized systems, establish intended-use boundaries, assess GxP impact at the function level, and document defensible quality-risk decisions.
- 7System Inventory and Ownership
- 8Intended Use and System Boundaries
- 9Function-Level GxP Risk Assessment
- 10Quality Risk Management Methods
- 11Risk Acceptance and Lifecycle Review
Modern Assurance Strategy
Develop practical assurance strategies that integrate traditional CSV responsibilities with modern risk-based critical thinking, proportionate verification, supplier evidence assessment, and quality governance.
- 12CSV and Assurance Lifecycle Principles
- 13FDA CSA Guidance and Scope
- 14Assurance Activity Selection
- 15Supplier Evidence and Critical Thinking
- 16Assurance Governance and Quality Oversight
Requirements and Validation Planning
Develop measurable requirements, fit-for-purpose specifications, lean validation plans, and traceable lifecycle documentation that demonstrate fitness for intended use.
- 17Lifecycle Planning and System Categorization
- 18User Requirements Specifications
- 19Functional and Technical Specifications
- 20Risk-Based Validation Planning
- 21Validation Documentation and Traceability
Testing and Release Decisions
Execute risk-based verification, produce reliable objective evidence, manage defects and deviations, and make documented decisions about regulated operational release.
- 22Risk-Based Verification Methods
- 23Functional Test Scenario Development
- 24Test Protocols and Objective Evidence
- 25Integration and Electronic Record Testing
- 26Validation Deviations and CAPA
- 27Validation Summary and Release Authorization
Cloud and Supplier Assurance
Assess cloud architectures, SaaS responsibilities, supplier qualifications, vendor evidence, contractual controls, security risks, and the continuity obligations associated with outsourced GxP systems.
- 28Cloud Computing and SaaS Responsibilities
- 29Supplier Qualification and Evidence Review
- 30Cloud Shared-Responsibility Mapping
- 31SaaS Validation and Vendor Evidence
- 32Supplier Agreements and Service Continuity
- 33Cloud Exit and Continuity Readiness
- 34Cloud Security and Cybersecurity Scope
Validated State and Inspection
Maintain trustworthy computerized systems throughout operation, preserve complete regulated records, control access and electronic signatures, and demonstrate ongoing compliance through periodic evaluation and inspection-ready evidence.
- 35Change Control and Configuration Management
- 36Data Integrity and Electronic Record Controls
- 37Security Access and Electronic Signatures
- 38Audit-Trail Review and Data Integrity Investigation
- 39Periodic Review and System Retirement
- 40Validated-State Health Check
- 41Backup Restoration and Record Retrieval Drill
- 42Inspection Readiness and Practical Capstone