Our Inspection Readiness Service

Prepare your systems, your evidence and your teams

We assess your level of readiness and recreate the conditions of an inspection to secure your responses, your practices and your GxP evidence.

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Inspection readiness Mock inspection Data Integrity CSV/CSA CAPA

When to prepare for an inspection

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

Our support

Readiness assessment

Assess your organisation, systems, practices and available evidence.

Evidence review

Verify the availability, consistency and quality of documents likely to be requested.

Mock inspection

Simulate document requests, interviews and situations encountered during an inspection.

Team preparation

Clarify roles and prepare staff to present their activities and evidence.

Prioritised action plan

Identify corrections and safeguards to implement before the inspection.

What you get

An objective view

Gaps and points of attention identified before the inspection.

Prepared teams

Roles, responses and reflexes practised under real conditions.

Accessible evidence

Expected documents are consistent, available and quickly presentable.

How the engagement unfolds

1

Scoping

Scope, authorities and scenarios.

2

Assessment

Documents, systems and practices.

3

Simulation

Requests, interviews and responses.

4

Securing readiness

Priorities, corrections and evidence.

Approach your inspection with a clear method

An initial conversation helps tailor preparation to your deadline and scope.

Schedule an initial conversation