Inspection readiness and audit response
Facing an FDA or EU inspection, or responding to one? Be ready for an inspection, or respond to one with credibility. We focus on computer systems, data integrity and Part 11.
The challenges this solves
An inspection is coming
We need to find and close gaps before investigators arrive.
We just received a 483
We need a credible response with root causes, evidence and a realistic plan.
A warning letter needs remediation
Corrective actions must be completed, verified and shown to hold.
What we deliver
- Mock audits with a risk-rated findings report
- Inspection readiness gap closure, with a focus on data integrity and Part 11
- SME preparation and narratives
- FDA 483 response support: draft response structure and evidence map
- Warning letter remediation with owners and timelines
- Root-cause-based CAPA plans
- Rapid mobilization of senior consultants
- Follow-up verification of closure
4 steps, clear deliverables
- 01
Assess
Run a mock audit or triage the findings you received.
You receive: Risk-rated findings report
- 02
Plan
Prioritize the response and remediation work.
You receive: Response and remediation plan with owners and timelines
- 03
Execute
Deliver corrective actions, evidence and narratives.
You receive: Corrective action plans and evidence map
- 04
Verify
Confirm closure and sustained control.
You receive: Closure verification
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
Can you guarantee the outcome of an inspection?
No. We commit to deliverables, scope and timelines. We do not promise regulatory outcomes.
What do you focus on?
Computer systems and data integrity, including Part 11 controls. We assess from an inspection-grade perspective.
How quickly can you start?
We mobilize senior consultants quickly. The start date is agreed when we scope the engagement.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Be ready, or respond with credibility
Tell us about your inspection or finding and get a scoped, fixed-fee quote.