GxP Audit and Inspection Readiness

GxP Audit Inspection readiness Mock inspection Data Integrity CSV/CSA

Would you be ready to respond today?

An inspection can happen at any time. Your ability to quickly produce reliable, consistent evidence is essential to demonstrate the compliance of your systems and control of your risks.

Evidence hard to find

Data scattered across several systems or uncontrolled versions.

Inconsistent documentation

Procedures, records and configurations that don't align.

Insufficiently prepared teams

Poorly anticipated interviews and uneven knowledge of requirements.

Known but uncontrolled deviations

Identified deviations with no effective action plan or structured follow-up.

Our Audit & Inspection support

A comprehensive, pragmatic approach to secure your audits and inspections.

Data Integrity Audit

We assess the governance, processes, systems and practices likely to affect the integrity of your GxP data.

This engagement is a good fit when you:

are preparing for a regulatory inspection
face recurring Data Integrity deviations
want to assess the maturity of a site or department
are rolling out a Data Integrity strategy
need to verify the effectiveness of a remediation programme

Assess your Data Integrity programme

Supplier and SaaS solution audits

Assess your vendors' ability to support your GxP activities.

Using an IT vendor or a Cloud solution does not transfer regulatory responsibility to the user organisation.

We assess the vendor's capabilities, quality system, development practices and the controls in place to protect your data and ensure service continuity.

The engagement may include:

preparation of the questionnaire and audit plan
assessment of the vendor's quality system
assessment of available documentation and tests
review of version and change management
assessment of access and incident management
review of backups and the continuity plan
assessment of data return and reversibility
clarification of client/vendor responsibilities
identification of additional controls needed

Possible deliverables:

Supplier questionnaire, audit plan, audit report, responsibility matrix, gap register and action plan.

This engagement is a good fit when you:

are selecting a new SaaS or Cloud solution
need to qualify a critical vendor
have little validation evidence
are renewing a contract or outsourced service
want to strengthen vendor oversight

Assess your vendor

Inspection readiness & mock inspection

Prepare your systems, your evidence and your teams.

We recreate the conditions of an inspection to assess your ability to respond to inspector requests and quickly present consistent evidence.

Preparation covers both documentary compliance and actual practices, as well as teams' ability to explain their organisation.

The engagement may include:

definition of scope and inspection scenarios
conducting a readiness assessment
preparation of an expected document list
review of procedures, files and available evidence
verification of consistency between documents and practices
simulation of document requests
interviews with teams
preparation of managers and subject-matter experts
debrief of observations and points of attention
definition of priority actions before the inspection
support organising the response room

Possible deliverables:

Preparation plan, document list, mock inspection report, interview prep sheets, observation register and priority action plan.

This engagement is a good fit when you:

have been notified of an upcoming inspection
are preparing for an FDA Pre-Approval Inspection
anticipate an ANSM, EMA or other authority inspection
are preparing for a client or partner audit
want to test your readiness with no immediate deadline

Prepare your inspection

Evidence-based preparation

We verify consistency between your procedures, your practices, your systems and the evidence actually available.

Scope

Understand your context and objectives.

Assess

Analyse what exists and identify gaps.

Simulate

Run a mock inspection.

Prepare

Implement corrective actions and train your teams.

Follow up

Track progress through to the real inspection.

Scopes assessed

We cover all areas critical to your audits and inspections.

Data Integrity

CSV/CSV validation

Audit trails

Access & privileges

Backup & restoration

Cloud & SaaS

Migration & archiving

IT quality governance

Useful audits, beyond a simple checklist

Our goal: to give you a clear view, concrete recommendations and a real strengthening of your compliance.

Identify the risks that truly matter

A risk-based analysis to focus on what matters most.

Formulate applicable recommendations

Concrete, realistic actions suited to your context.

Prepare clear, defensible responses

Factual elements to respond to inspectors with confidence.

Frequently asked questions

What is the difference between an internal audit and a mock inspection?

An internal audit assesses compliance of a defined scope. A mock inspection more directly recreates the conditions of a regulatory inspection: document requests, interviews and presentation of evidence.

How do you prepare teams for interviews?

Preparation includes clarifying roles, reviewing sensitive topics and running Q&A simulations based on each participant's actual activities.

What should be presented during a CSV or Data Integrity inspection?

It depends on the system and its use: validation strategy, requirements, risk analyses, tests, access management, audit trails, backups, changes, incidents and periodic reviews.