Why is documentation important in validation processes?
Documentation is crucial in validation as it provides a clear record of procedures, results, and compliance.
Can you give examples of what should be documented?
Sure! Key elements include validation plans, test protocols, results, and any deviations from expected outcomes.
How does good documentation impact regulatory compliance?
Good documentation ensures that all processes are traceable and verifiable, which is essential for meeting regulatory standards.
What are the risks of poor documentation?
Poor documentation can lead to misunderstandings, non-compliance, and potential failures in validation, risking product quality.
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