CSVtoCSA learning resources
Study ten CSV and CSA topics, work through practical examples, and complete a 50-question assessment.
Learning objectives, topic-specific explanations, worked examples, evidence expectations, and revision exercises. Includes an Agile PLM capstone on GxP Quality documents and change approvals.
Download handbook PDFDownload editable handbook (Word)Five single-best-answer questions per module, including 40 application questions and 10 foundation questions. The final page includes a candidate answer sheet for recording your responses.
Download exam PDFDownload editable exam (Word)The complete learner pack also contains the ten original Word modules and instructions for using the materials.
Prepare for the assessment
Study the handbook and complete its exercises before taking the exam. For an administered assessment, follow your course administrator’s instructions.
Wrong, blank, or multiple responses receive zero points. There is no negative marking. These are proposed course settings, not regulatory certification requirements.
What you’ll study
Connect intended use, risk, controls, and objective evidence.
Define the process, system boundary, regulated records, and decision reliance.
Write testable requirements and connect them to risk and evidence.
Evaluate failure modes, impact, control effectiveness, and uncertainty.
Choose scripted, exploratory, negative, boundary, and regression testing.
Assess supplier capability and identify gaps in evidence for local use.
Screen Part 11 applicability and assess attribution, history, and record retention.
Verify data meaning, completeness, exception handling, and change impact.
Address changes, incidents, access, recovery, periodic review, and retirement.
Define decision authority and evaluate critical misses and human review.