Quick Answer A Requirements Traceability Matrix, or RTM, is a controlled table that links each approved user requirement to the design documents, risk controls, verification activities, test results, deviations, and final evidence used to demonstrate compliance. In a cleanroom project, an RTM helps confirm that every relevant requirement has been addressed through DQ, FAT, SAT,
A validation master plan defines the overall strategy for cleanroom qualification and validation. Learn how to establish system scope, responsibilities, risk-based testing, lifecycle documentation, and requalification requirements.
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Quick Answer Installation Qualification (IQ) is the documented process of verifying and recording that equipment, systems, or facilities have been installed according to approved design documents, manufacturer recommendations, engineering specifications, and applicable regulatory requirements. For cleanroom projects, IQ confirms that critical systems—including HVAC equipment, cleanroom envelope systems, utilities, monitoring devices, and cleanroom equipment—have been correctly
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