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 FDA’s
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.
FDA QSR Audit Checklist