Xray

Service Description

Xray & GxP V&V Training - Jira, traceability and regulatory reporting Jira combined with Xray lets you structure the entire test cycle in a V&V approach compliant with GxP requirements (GAMP 5, Annex 11, 21 CFR Part 11). This training gives you the keys to use these tools in an operational and auditable way. Objective: This training aims to enable participants to manage a testing activity in Jira/Xray, build a defensible traceability matrix and produce the reports expected during GxP software validation. Training modules: 1. Jira fundamentals in a validation context: - Issues, epics, links, JQL, reframed with a V&V focus. 2. Anatomy of an Xray Test: - Test, Test Plan, Test Suite, Test Execution: roles and articulation within an IQ/OQ/PQ cycle. 3. Writing test cases: - Steps, pass/fail criteria, regulatory best practices (FDA, ANSM). 4. Execution and defect management: - Running an execution, recording results, managing retests and cycles. 5. Requirements - Tests - Results traceability: - Building the RTM, coverage, gap identification. 6. Metrics and dashboards: - Pass rate, test coverage, project reporting and client tracking. 7. Document generation with Xporter: - Producing protocols, reports and RTM in Word/PDF from Jira. 8. Hands-on workshop: - Working on a simulated validation project, from drafting to the final deliverable. By the end of this training, you will be able to structure an Xray project compliant with a V&V approach, write auditable test cases, manage executions and generate the deliverables expected by your clients and by regulatory authorities.