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ROI CalculatorEquipment Calibration is confirming and adjusting measuring equipment, so results are accurate and traceable.
FDA 21 CFR 211.68 requires equipment used in production and testing to be routinely calibrated and checked according to a written program. ISO 9001 and ISO 13485 require monitoring and measuring equipment to be calibrated against traceable standards with records maintained.
Why it matters: bad calibration means bad data, which drives batch failures and audit findings. This eventually adds up to the costs of poor quality.
