Ensure Successful FDA QSIT Inspections
Avoid the guesswork in preparing for a QSIT audit
The Quality System Inspection Technique (QSIT) instructs U.S. Food and Drug Administration (FDA) staff on how to assess medical device manufacturers’ compliance with quality system regulations.
The FDA uses a “top-down” approach to look at your company’s subsystems (corrective action/preventive action (CAPA), design controls, process controls, change controls, etc.). This review is to ensure that your company has sufficiently defined and documented the subsystems’ procedures. Is your documentation complete, controlled, up to date, and ready for an audit?
- Learn about four solutions that can keep you audit-ready.
- Learn how you can track all your documentation and ensure it’s ready for a QSIT audit.
- See how audit software is a necessity for a QSIT review.
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The Quality of Repurposed Med Devices Surpasses Original Products
Northeast Scientific is a market leader in high-end peripheral vascular catheter remanufacturing. The intense regulatory scrutiny on their processes makes it important that the production and quality departments work in sync. See how they use MasterControl’s Quality Excellence software to maintain high levels of quality while getting their products back into doctors’ hands as soon as possible.
I like having the ability to take paper-based records and create digital customisations for the end users. Some of the best things about this is reducing the time spent reviewing batch records and the reduction of errors from GDP perspective.
Learn More about MasterControl's QMS Software
Improve Audit Efficiency Across the Quality Landscape
A digitized quality management system (QMS) is essential for efficient document control tasks. But it’s also valuable in simplifying training, CAPA, supplier management, audits, and more. The same interconnectivity that improves document control also streamlines the interaction between different aspects of a QMS. With a unified system that connects, stores, and tracks your quality information, your organisation can maintain a state of continual readiness for QSIT audits and other types of inspections.
Easily Meet FDA Regulatory Requirements
Make quality a differentiator in getting products approved and on the market. A digital quality management system like MasterControl Quality Excellence, automates your quality tasks at every phase of the product’s life cycle. Plus, when you’re trying to satisfy regulatory agencies like the FDA, audit software built into the Quality Excellence solution helps ensure inspection readiness.
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Contact us today to find out how MasterControl solutions can streamline your quality management processes.
