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EU GMP · 21 CFR 210/211 · ICH Q7A

Inspection Readiness

A confidential external stress test of your sites, before an authority or a customer runs one for you.

We turn the audit, deviation, CAPA and quality data you already hold into one normalised, benchmarked readiness view per site. Report in 5 to 10 days, with no workload for your sites beyond a secure upload.

Pharmaceutical manufacturing line
What you get
One readiness report per site
Risk heatmap, CAPA robustness and a prioritised action plan.
6,000+GMP audits performed
80+countries in our audit dataset
1,500+clients rely on Qualifyze
5 to 10 daysfrom upload to report
Why now

The bar for readiness just went up

In May 2025 the FDA moved to expand unannounced inspections at manufacturing sites outside the US, and is using AI-enabled tools such as its ELSA initiative to select inspection targets from data patterns. The EMA and other authorities are moving the same way, while customer audits grow more frequent and more rigorous.

~10%
of FDA inspections at non-US sites arrived unannounced in FY2023. That share is set to rise sharply.
2×
more serious deficiencies found by the FDA at non-US sites than at US sites, even with advance warning.
~1,000
FDA drug quality inspections a year, 62%+ of them outside the US, now shifting toward no notice.

Continuous readiness is now the baseline. When notice disappears and data decides who gets inspected, the question is simple: what would an inspector write up if they walked into your site tomorrow, unannounced?

The blind spot

Most sites cannot answer that question from the inside

Not because the quality system is weak, but because internal audits, deviations and CAPAs are recorded in different systems, in different formats, and read by the same people who wrote them. There is no external lens and no comparison to how peer sites are actually assessed.

6–18 mo average time to detect a supplier quality issue after onset
$150–250k typical cost exposure per FDA 483 issuance
€5–20m cost of a single recall in direct and reputational damage
Illustrative single-occurrence ranges, not Qualifyze guarantees.
No external view
Your last honest outside read was the last inspection, and it came with findings attached.
Evidence is fragmented
Findings, deviations and metrics live in separate systems, so patterns across sites never surface.
CAPA robustness untested
Closed on paper is not the same as effective. Repeat findings are the most cited pattern of all.
No credible benchmark
Without peer comparison, you cannot tell a tolerable weakness from an inspection trigger.
The assessment

A Site Risk & Inspection Readiness Assessment

An expert-reviewed, confidential stress test of your sites' inspection readiness and documentation quality. It uses evidence you already hold, benchmarks it against thousands of comparable audits, and tells you what an external assessor would challenge first.

Know where your risk truly lies
One normalised, benchmarked risk view per site, built from your own data.
Prioritise with confidence
A risk heatmap across GMP quality systems shows where to act first.
Prepare for every inspection
Unannounced, scheduled or customer audit: close gaps before they become observations.
Benchmark every site objectively
Compared against thousands of comparable audits performed worldwide.
Reduce burden, not oversight
An external lens without your sites hosting another onsite audit.
A clear path forward
A CAPA robustness review plus a prioritised, recommended action plan.
How it works

Zero effort beyond a secure upload

No new documentation, no interviews, no walkthroughs, no site time. Three steps from upload to report.

1
Share existing evidence
Securely upload audit reports, CAPA logs, deviation and complaint trends, SOPs and quality metrics. Nothing new is created; redaction is fine.
2
Senior GMP expert review
Your evidence is assessed and enriched with our cross-industry audit pattern intelligence and public regulatory signals, to produce one normalised, benchmarked risk view per site.
3
Confidential readiness report
Inspection risk per site, a GMP systems heatmap, CAPA robustness and a prioritised action plan, delivered in 5 to 10 days, for your eyes only.
Every conclusion in the report comes from a senior Qualifyze GMP expert, with AI extending their reach across the full breadth of your documentation. Always a human in the loop.
What you share

Five sets of materials you already hold

A detailed GMP documentation index is provided separately as the Document Request Checklist. Redaction is welcome: patterns matter more than product names.

Nothing is created for this assessment
Site & quality system documentation
SMF, Quality Manual / PQS, licences, org charts, self-inspection reports.
Quality event records
Deviations, change controls, CAPAs, complaints and their logs.
Production & laboratory records & product reviews
KPI dashboards, OOS / RFT / rejection trends, APR / PQR reports.
Qualification & validation evidence
Equipment, utilities, CSV, process and cleaning validation packages.
Production & laboratory records
Batch records, IPC data, OOS / OOT investigations, stability data.
Who it is for

Built for the people who carry the risk

Heads of Quality & QP
Own sites facing unannounced inspection. Get an external read before an authority provides one.
CMO and CDMO leadership
Demonstrate readiness to clients with evidence, and reduce the number of duplicative customer audits.
Supply chain and external ops
Cover critical GxP partners (CMOs, CDMOs, labs) where a shutdown stops your supply.
Why Qualifyze

The largest independent GMP audit dataset in the world

Thousands of site audits across 80+ countries. In scale, probably second only to the regulators themselves. Our findings have repeatedly anticipated issues later cited in regulatory actions, and authorities are engaging with us on how data can inform inspection prioritisation.

~250
onsite audits performed every month
80+
countries covered by our audit dataset
400+
qualified auditors and senior GMP experts
10+
health authority integrations, incl. FDA, EMA, MHRA
Data security

Your documents never leave a controlled environment

All analysis runs in a strictly controlled environment under GDPR-grade controls. Documents are never shared with third parties, and source files can be deleted after delivery on request.

ISO 9001 ISO 27001 SOC 2 Type 2 ISO 27701 · PIMS ISO 42001Coming soon
Confidentiality & scope

The report is for your eyes only

It is never shared with your customers or any third party, and it is fully separate from any customer-mandated audit.

This is not a regulatory inspection and not a replacement for an onsite audit. It is a fast, evidence-based external stress test that complements your internal audit programme, and tells you where each is needed most.
Live walkthrough · no site time required

Walk through a real readiness report with a Qualifyze GMP expert

Thirty minutes, nothing to prepare. A senior GMP expert walks you through a real, anonymised assessment section by section, so you can see exactly how this would read for your own sites.

Executive summary and prioritised action plan
The part quality leadership acts on: findings ranked high, medium and lower priority, each tied to the evidence behind it.
Inspection risk assessment and CAPA robustness
Inspection history, a peer heat-map against sector trends, a gap analysis against the applicable GMP guide, and an evaluation of how well past CAPA commitments actually held.
The same expert answers your questions on scope, timelines and what an assessment would cover for your own sites.
Request the walkthrough
We reply within one business day to schedule. No site data required to book.
By requesting the walkthrough you agree to be contacted by Qualifyze about Inspection Readiness. Confidential, shared under audit engagement.