Inspection Readiness & Support
Inspection readiness refers to an organization’s ability to support a Regulatory inspection with partial or no notice. Being capable of demonstrating competency when answering a health authority’s questions, performing under stress, maintaining a kind and professional demeanor, adapting to the health authority’s information requests, and managing new or absentee subject matter experts.
GxP Solutions can help your organization conduct mock inspections third-party internal audits and more to keep your sites prepared.
GxP Solutions can provide the following services:
- Conduct Mock Inspections.
- Conduct Third-Party Internal audits (e.g., system and process audits).
- Conducting Pre-approval inspections
- Pressure test SME and site management in answering health authority questions and explaining technical information.
- Regulatory inception training on how to run a back room and front room efficiently.
- Identifying roles, responsibilities, and equipment needed to host an inspection.
- Pre-audit risk table development to self-identify risk and develop mitigation plans and CAPAs.
- Develop storyboards to explain hard-to-understand issues, deviations, and CAPAs that evolved with time, changes in budget, and loss of knowledge with staff turnover.
- Train staff on the do’s and don’ts when hosting a health authority inspection.
- Maintaining an inventory of frequently requested documents and procedures.
