VAL
Computer System Validation & Testing
CSV Associate / QA Tester
Pharma; CRO; Biotech; Medical Device
Understanding regulated intended use is as important as testing technique.
Bridge skills
SDLC; risk; requirements; traceability; testing; data integrity
Competencies
GxP and regulated-system fundamentals
Understand intended use, risk and evidence expectations.
SDLC and validation lifecycle
Connect planning, requirements, testing and release evidence.
Risk assessment
Prioritize controls and testing based on risk.
Requirements and traceability
Maintain testable requirements and links to evidence.
Test case design and execution
Create clear steps, expected results and objective evidence.
Data integrity and audit trail
Recognize controls supporting trustworthy electronic records.
Clear regulated documentation
Write complete, reproducible and objective records.
Defect and deviation handling
Document facts, impact, resolution and retest.
Change control
Assess and document controlled system changes.
Supplier/system documentation review
Assess whether documents are relevant and adequate.
Practice labs
Risk and Traceability
Do not declare a system validated from this exercise.
Failed Test Investigation
Do not rewrite evidence to make a failed test pass.