Senior Compliance Scientist
GxP Regulatory Audit Toolkit
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:
- Process Flow Chart
- Preparation Checklist Template
- Planning Template
- Notification Letter Template
- Execution Checklist Template
- Report Template
- Observations Tracking Template
- DocumentTracking Template
- Closure Template