Expert Audits

Audits are where a quality system meets reality. Whether you're choosing a new vendor, getting ready for a regulatory inspection, or working through findings from one, the stakes are the same: you need to know exactly where you stand, and what to do about it.

Vendor Audits

Before you commit to a new system or supplier, we assess it for life-science suitability — so you're not finding out about a gap after you've already gone live.

Preparation for Regulatory Audits

Getting ready for an MHRA, FDA, or PIC/S-aligned inspection means knowing your computer system validation, data integrity, and 21 CFR Part 11 posture cold — not guessing. A pre-audit evaluation finds the gaps while you can still close them.

New: try the GxP Readiness Planner free, right now. Answer a short set of plain-language questions about a specific system, and see your readiness score against GAMP5, 21 CFR Part 11, and EU Annex 11 — plus a backwards-scheduled plan counting from your next self-inspection, sponsor audit, or go-live date. Nothing you enter leaves your browser. Try it free →

Action Items Solution

If a pre-audit (or a real one) turns up gaps, we help you plan and close them — properly, not just enough to pass.

If the Readiness Planner shows you're in good shape, the relevant module in our CSV training course walks you through closing the remaining gaps yourself, at your own pace.

If your situation is more complex, or your timeline is tight, that's what we're here for.