Which term means documented evidence that a system meets design requirements?

Question

Options

• AQualification
• BCalibration
• CCommissioning
• DVerification

• A
  80% (20)
• B
  12% (3)
• C
  4% (1)
• D
  4% (1)

Explanation

Qualification refers to documented evidence demonstrating that a system, equipment, or process consistently meets its design requirements and specifications - making option A correct. Calibration (B) is the process of comparing a measurement instrument against a known standard to ensure accuracy, not about design requirement evidence. Commissioning (C) involves the process of starting up and testing a system to confirm it operates as intended, but it's the activity itself, not the documentation of design conformance. Verification (D) is a broader term meaning checking that something is correct or true, but in regulated industries (pharmaceutical, engineering), it typically refers to confirming a process or method works - not specifically the documented evidence that design requirements are met.

Memory tip: Think "Q for Qualification = Quality documentation" - it's the formal, documented proof that your system is qualified to meet its design specs, commonly used in GMP/FDA-regulated environments.

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