Our Inspection Readiness Service
We assess your level of readiness and recreate the conditions of an inspection to secure your responses, your practices and your GxP evidence.
An inspection has been announced
You are preparing for an FDA Pre-Approval Inspection
A client or partner audit is approaching
You want to test your level of readiness
Assess your organisation, systems, practices and available evidence.
Verify the availability, consistency and quality of documents likely to be requested.
Simulate document requests, interviews and situations encountered during an inspection.
Clarify roles and prepare staff to present their activities and evidence.
Identify corrections and safeguards to implement before the inspection.
Gaps and points of attention identified before the inspection.
Roles, responses and reflexes practised under real conditions.
Expected documents are consistent, available and quickly presentable.
Scope, authorities and scenarios.
Documents, systems and practices.
Requests, interviews and responses.
Priorities, corrections and evidence.
An initial conversation helps tailor preparation to your deadline and scope.
Schedule an initial conversation