| Role | Key Responsibilities | Training Focus Area | |------|----------------------|----------------------| | | Define requirements, accept risk | GAMP 5 overview, risk management, system lifecycle | | Quality Assurance (QA) | Approve validation deliverables | Regulatory expectations, audit trail review, data integrity (ALCOA+) | | Validation Engineers | Execute validation protocols (IQ/OQ/PQ) | Risk-based testing, traceability matrix, change control | | IT / System Administrators | Manage access, backups, security | 21 CFR Part 11 compliance, audit trails, disaster recovery | | Developers / Automation Engineers | Configure or code systems | GAMP software categories (3,4,5), agile in GxP, unit testing | | End Users (Operators) | Use system for production | Good documentation practices, avoiding data integrity violations |