An FDA QSIT inspection is a "top-down" inspection (vs. a "bottom-up" inspection) and rather than focusing on many minor deviations, it focuses on systemic issues that can primarily be detected within quality-related documentation and subsequent document sampling.
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An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses. When an investigator conducts an FDA QSIT inspection, medical device companies can expect shorter audits and more serious repercussions---especially to upper management.
To prepare your company for an FDA QSIT inspection, documentation must be controlled and continually reviewed/compared against actual processes. Maintaining this level of document/process control requires advanced software solutions. MasterControl, a compliance software company, specializes in document control, audit, and process management solutions for highly-regulated environments.
To learn more about FDA QSIT and the solutions that make it easy to collaborate on, retrieve and store essential quality documentation, please feel free to contact a MasterControl representative.
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