Get ready before the investigator arrives — or respond credibly when findings land. Mock audits, inspection readiness, and structured support for Form 483 and Warning Letter responses.
Services
How we help
From proactive readiness to urgent response, focused on the computer-system and data-integrity areas inspectors probe.
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Mock audits
A dry run against the standard an FDA/EMA investigator applies — findings before they count.
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Inspection readiness
Documentation, narratives and SME prep so your systems story holds up.
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483 response support
Structured, credible responses with realistic corrective-action plans.
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Warning Letter remediation
Sequenced remediation that addresses root cause, not just symptoms.
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Rapid mobilization
Senior help when timelines are tight and stakes are high.
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CAPA support
Corrective and preventive actions that close findings and stay closed.
Deliverables
What you receive
- Mock-audit findings report (risk-rated)
- Inspection-readiness gap closure plan
- Data-integrity and Part 11 focus areas
- SME preparation and narratives
- Draft response structure and evidence map
- Root-cause-based corrective action plans
- Remediation roadmap with owners and timelines
- Follow-up verification of closure
Deliverable-level commitments. We provide defensible, well-structured responses and remediation — we don’t promise regulatory outcomes; we make your position as strong as the facts allow.
How it works
Ready before, credible after
STEP 01
Assess
Mock audit or finding triage.
STEP 02
Plan
Prioritized response and remediation plan.
STEP 03
Execute
Corrective actions, evidence, narratives.
STEP 04
Verify
Confirm closure and sustained control.
Why SQA Solution
Why teams choose us
Inspection-grade perspective
We assess the way an investigator does, so nothing is a surprise on the day.
Computer-system & DI focus
The areas most likely to generate findings are our core.
Senior, fast
Experienced consultants who can mobilize quickly.
Root-cause discipline
Remediation designed to hold, not just to close the letter.
Fixed-fee, transparent scope
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteBe ready — or respond with credibility
Whether you’re preparing or already have findings, tell us where you stand and we’ll scope the support.
Request a Quote
