The duty of every competent regulatory manager and quality manager is to use the QSIT questions as well as the related regulations to see how their QMS is complying.
QSIT incorporates seven subsystems and provides guidance to its inspectors on auditing each of the subsystems.
The FDA's QSIT and QSIT workshops should be a source of study for all medical device manufacturers," said Kolka.
QSIT determines compliance by auditing these subsystems and related records.
Change controls: The FDA expects all medical device companies to maintain a secure, comprehensive centralized system to manage all quality procedures, product documents and manufacturing procedures, and to track all changes for easy retrieval to support QSIT audit requirements.
Most life-sciences companies currently manage quality and address the QSIT requirements using a combination of manual paper-based processes or discrete-point solutions for document authoring and change management, quality-event management, program management, and management reviews.
PLM supports the creation of a compliant data set consisting of all documents, decisions, and activity to support each of the QSIT systems.
The ultimate PLM solution for a medical device company integrates the company's quality-management system with the QSIT compliant dataset to share quality data across the enterprise and automate challenging compliance tasks.
Managing programs across the QSIT subsystems is even more difficult because it is not standardized, creating redundant information, inefficiencies, and errors in the transfer.
When QA-RA processes require cross-functional input with multiple QSIT systems, it often goes into a black hole, with no visibility into status.
100, cGMP, ISO 9000/ 13485/14971, QSIT
and automated systems for quality, has CAPA evolved during the past decade, and are we moving in the right direction?