FDA QSIT - Quality System Inspection Technique

FDA QSIT (Quality System Inspection Technique) is the name of the document that provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer's compliance with quality system regulations.

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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The Value of Studying and Utilizing FDA's QSIT Manual

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Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud
White Paper: How to Successfully Complete an FDA Inspection White Paper: The Value of Studying and Utilizing FDA's QSIT Manual White Paper: FDA Inspections of Clinical Investigators: Are You Ready? White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
Kit: 11 Free Resources to Boost Your FDA Readiness

Prepare Your Company for an FDA QSIT Inspection

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.

Documentation Must be Controlled Before an FDA QSIT Inspection

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.

Learn More About FDA Quality System Inspection Technique

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.