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  FDA QSR Audit Checklist

Standard checklists can serve as valuable tools in assisting you in the planning, implementation, and internal auditing of your FDA QSR quality management system. Since individual companies need to interpret and "tweek" the implementation of the QSR to meet their individual needs and unique characteristics, standard checklists also need to be "tweeked". Although every effort has been made to provide you with a comprehensive audit checklist, you may use the diskette to select and modify the checklist to best suit your needs.

The FDA QSR AUDIT CHECKLIST addresses all of the requirements of the FDAs Quality System Regulation (QSR) and assists in the planning, implementation, and internal auditing of your FDA QSR quality management system. The checklist provides a baseline at the start of implementation to identify what needs to be done to meet the requirements of the QSR (i.e. gap analysis), and during implementation can be used as a reference to measure progress and verify compliance. The checklist also serves as an invaluable training tool for management and internal auditors by identifying the types of questions or issues that need to be addressed to show compliance with the QSR.

The FDA QSR AUDIT CHECKLIST can be used effectively in the following ways:

To Establish a Baseline and Action Plan: The FDA QSR checklist helps to provide a baseline at the start of the implementation to identify what needs to be done to ensure your quality management system is compliant with FDA's QSR (i.e. gap analysis). An action plan can then be developed to identify any tasks that need to be completed and identify those personnel/functions responsible for implementing corrective action.

As a Training Guideline/Tool: The FDA QSR checklist serves as a great training tool for the organization and internal auditors by helping personnel to understand the actual FDA QSR requirements and identifying the type of documentation needed to satisfy the regulation.

To Perform Internal Audits: Checklists help to ensure that audits are conducted in a systematic and comprehensive manner (i.e. in accordance with an audit plan), and that the proper evidence and documentation are obtained (i.e. evidence of an audit trail). The FDA QSR checklist clearly defines what you need to audit and provides an audit trail to satisfy QSR compliance requirements.


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