Validation is a systematic process of checking if a product, software, or system meets specific requirements and works as intended. It's like a thorough inspection that ensures everything functions correctly before it reaches customers or users. Quality Assurance teams perform validation to catch problems early, save money on fixes, and maintain product quality. While testing focuses on finding bugs or issues, validation is broader and confirms that the product fulfills its intended purpose and meets user needs.
Led Validation efforts for new healthcare software systems
Performed System Validation and Process Validation for manufacturing equipment
Created comprehensive Validation protocols and test plans for pharmaceutical products
Managed Software Validation activities across multiple development projects
Typical job title: "Validation Engineers"
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Q: How would you develop a validation strategy for a new product?
Expected Answer: A senior candidate should explain how they would review requirements, create validation plans, consider risk assessment, establish acceptance criteria, and coordinate with different teams to ensure comprehensive validation coverage.
Q: Tell me about a time you had to handle a complex validation failure. How did you address it?
Expected Answer: Look for answers showing leadership in problem-solving, communication with stakeholders, root cause analysis skills, and ability to implement corrective actions.
Q: What's the difference between verification and validation?
Expected Answer: Should explain that verification checks if the product is built correctly according to specifications, while validation ensures the product meets actual user needs and requirements.
Q: How do you document validation activities?
Expected Answer: Should discuss creating clear validation protocols, test plans, recording results, maintaining traceability to requirements, and proper documentation of any deviations or issues found.
Q: What is validation and why is it important?
Expected Answer: Should explain that validation ensures products work as intended and meet user needs, helping prevent issues before they reach customers.
Q: What are the basic steps in a validation process?
Expected Answer: Should describe the basic steps: planning, writing protocols, executing tests, documenting results, and reporting findings.