QSIT Inspections

ARTICLES

What to Expect During the QSIT Inspection: Production & Process Controls

The purpose of the production and process controls system inspection is to verify the existence and effectiveness of the subsystem used to ensure that the processes used to produce the medical devices or drugs that the firm manufactures meet the specifications that apply to such products. Read More

What to Expect During the QSIT Inspection: Medical Device Tracking

The purpose of the Medical Device Tracking Regulation is to ensure that manufacturers and importers of certain medical devices can expeditiously locate and remove these devices from the market and/or notify patients of significant device problems. Read More

What to Expect During the QSIT Inspection: Medical Device Reporting

The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt identification, timely investigation, reporting, documentation, and filing of device-related death, serious injury, and malfunction information. Read More

What to Expect During the QSIT Inspection: CAPA Subsystem

The purpose of the CAPA inspection is to verify the existence and effectiveness of the subsystem used to collect and analyze information, investigate product and quality problems and take effective corrective action to prevent their recurrence (or preventive action to prevent them from occurring in the first place.) Read More

What to Expect During the QSIT Inspection: Design Controls

The purpose of the design control subsystem inspection is to verify the existence and evaluate the effectiveness of design process controls implemented to ensure medical devices meet user needs, intended uses and specified requirements. Read More

What to Expect During the QSIT Inspection: Management Controls

Because everything else stems from management commitment, the QSIT inspection should start and end with the management subsystem inspection and determination of whether executive management ensures that an adequate and effective quality system has been established (defined, documented and implemented) at the firm. Read More