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Rachel Leahy, PhD
Senior Compliance Scientist
Kymanox

GxP Regulatory Audit Toolkit

FDA Mock Audit Preparation, Execution, and Reporting for Drugs, Biologics, and Devices
Product Description

How ready are you for an audit from a regulatory body?
Regulatory bodies, such as FDA, conduct regular detailed inspections of companies to determine their compliance with the corresponding regulations. Depending on the level of noncompliance, these inspections can lead to administrative actions, such as product recalls, withdrawals of product approvals, license revocations. In severe violations judicial actions can be taken, such as seizures of violating products, injunctions, and certain civil penalties.

This package provides a universal GxP Audit Toolkit that can be customized to fit any organization and provides a comprehensive list of tasks and activities that should be performed by multiple departments in preparation for a regulatory inspection or audit.

This product includes the following universal documents and templates, all in editable format:
 - Tips
 - Process Flow Chart
 - SOP
 - Preparation Checklist Template
 - Planning Template
 - Notification Letter Template
 - Execution Checklist Template
 - Report Template
 - Observations Tracking Template
 - DocumentTracking Template
 - Closure Template
 
 

PACKAGE TYPE Free Starter Standard Pro
Purchase Price $0 $499 $699 $899
Tips for Auditors and Auditees PDF yes yes yes yes
Process Flow Chart (1 page) PDF yes yes yes yes
Editable SOP (9 pages) Word no yes yes yes
Editable Process Flow Chart (1 page) Visio no yes yes yes
Editable Preparation Checklist Template (20 pages) Word no no yes yes
Editable Planning Template (1 page) Word no no yes yes
Editable Notification Letter Template (6 pages) Word no no yes yes
Editable Execution Checklist Template (23 worksheets) Excel no no yes yes
Editable Report Template (8 pages) Excel no no yes yes
Editable Observations Tracking Template (1 worksheet) Excel no no yes yes
Editable Document Tracking Template (1 worksheet) Excel no no yes yes
Editable Closure Template (1 page) Excel no no yes yes
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