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Inspection Readiness

Know where an inspector would look, before the inspection is scheduled.

A confidential review of the SOPs, validation and quality reports, deviation, CAPA and batch records you already hold, read against the standard a specific authority will hold you to, and handed back as a prioritized map of your gaps.

Pharmaceutical manufacturing line
One report per site
No workload for your sites beyond a secure upload
6,000+GMP audits performed
80+countries in our audit dataset
1,500+clients rely on Qualifyze
5 to 10 working daysfrom upload to report
Why now

Inspections are more selective, sharper, and increasingly risk-targeted.

The question is no longer whether you will be inspected on a fixed schedule. It is whether your risk profile puts you near the top of the list, and whether your documentation holds up when it does.

01 · Selection
Risk-based selection is the rule now.
The FDA's published Site Selection Model scores every site on its compliance history, time since last inspection, the record of its country or region, hazard signals like recalls and field alerts, and product risk. The highest scores get the visit.
Source: FDA CDER MAPP 5014.1
02 · Outcomes
Nearly 1 in 5 inspections ends in official action.
Across 1,309 drug quality and MRA partner inspections in FY2025, 18% closed as Official Action Indicated. US sites ran higher, at 21.6%.
Source: FDA FY2025 Report on the State of Pharmaceutical Quality
03 · Notice
Advance warning is being withdrawn.
In May 2025 FDA moved to expand unannounced inspections at foreign sites, backed by an Executive Order on risk-based inspection. Continuous readiness is now the baseline.
Source: FDA press announcement, 6 May 2025
04 · Consequences
A site's status can hold an approval.
Of nearly 10,000 applications needing a facility assessment in FY2024 and FY2025, 28% drew a Complete Response Letter. 43% of those were facility withholds, most at sites already carrying OAI status. FDA's own conclusion: many were preventable.
Source: FDA FY2025 Report on the State of Pharmaceutical Quality

When notice disappears and data decides who gets inspected, one question matters. What would an inspector write up if they walked into your site tomorrow?

The blind spot

Most sites cannot answer that question from the inside.

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

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 closed in practice, and a finding that comes back is the one inspectors escalate.
No credible benchmark
Without peer comparison, you cannot tell a tolerable weakness from a citation trigger.

Three citations dominated FDA facility withholds in FY2025: inadequate investigations of discrepancies and batch failures, quality control unit procedures not written or not followed, and inadequate microbiological control. All three are documentary, and all three are visible in records you already hold.

Source: FDA FY2025 Report on the State of Pharmaceutical Quality
What it is

A confidential, one-time review of your own documentation.

This is a documentary review of a single site. An inward-looking stress test. Your records are read against the standard a specific authority will apply, so you find the gaps first, on your own terms.

Because it works only from documents you already maintain, there is nothing new to write and nothing filed with anyone. The value is simple: the questions an inspector would ask, answered while you still have time to act.

Confidential to you
The report is never shared with regulators or with your customers. It exists to prepare you, not to represent you.
Not an audit
It does not replace your onsite audits or certifications. It gets you ready for them.
Walled off
Your data package is firewalled from any future Qualifyze third-party audit of your site.
Expert sign-off
Every finding is reviewed and signed off by a senior GxP expert before it reaches you.
What you get

One report. Three answers.

1
Inspection risk assessment
Where your documentation would draw questions, ranked by how material each gap is to an inspection outcome, not by how many you have.
2
CAPA robustness evaluation
Whether your corrective actions actually hold. Closed on paper versus closed in practice, and where recurrence signals a root cause that was never resolved.
3
Recommended action plan
A prioritized, sequenced set of fixes, scoped to the time you actually have before the inspection, so the list is a plan and not a wish.
What we compare against

Three reference points most reviews do not have.

Public regulatory records
Inspection findings and outcomes published by health authorities. What actually gets cited, and how often.
Our own audits at your site
Where we have audited you before, we carry that history into the review instead of starting cold.
6,000+ audits of comparable sites
The recurring findings our auditors see across similar operations. The patterns that tend to matter.
~250 onsite audits performed every month
80+ countries covered
400+ qualified auditors and senior GMP experts
A materiality lens, not a prediction. It tells you which gaps tend to matter, not what any one inspector will decide on any one day.
How it works

Zero effort beyond a secure upload.

No new documentation. No interviews. No walkthroughs. No site time.

1
Secure upload
You share five sets of existing materials through an encrypted workspace. Redaction is welcome. Patterns matter more than product names.
2
Expert-led review
Your evidence is read against current GMP expectations and the three reference pools above. We use AI to cover the full document set rather than a sample, and a senior GxP expert reviews and signs off on every finding before it reaches you.
3
Readiness report
You receive the three-part report in 5 to 10 working days. Inspection risk, CAPA robustness, and a prioritized action plan. For your eyes only.
What we review

Five sets of materials you already hold.

Nothing is created for this assessment. Redaction is welcome, since patterns matter more than product names. A detailed GMP documentation index is provided separately as the Document Request Checklist.

01
Site and quality system documentation
SMF, Quality Manual and PQS, licenses, org charts, self-inspection reports, SOPs and quality policies.
02
Quality event records
Deviations, change controls, CAPAs, complaints and their logs.
03
Qualification and validation evidence
Equipment, utilities, CSV, process and cleaning validation packages, environmental monitoring and stability reports.
04
Production and laboratory records
Batch records, analytical and IPC data, OOS and OOT investigations.
05
Quality metrics and product reviews
KPI dashboards, OOS, RFT and rejection trends, APR and PQR reports.
Who it is for

Whoever owns the site's readiness.

Heads of Quality and Regulatory Affairs
Walk into your next inspection already knowing where the gaps are, and having closed the ones that matter most.
CMOs and CDMOs
Build internal confidence ahead of client audits and regulatory inspections, without exposing anything you would rather fix first.
Confidentiality and scope

The report is for your eyes only.

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 II ISO 27701 ISO 42001
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, anonymized assessment section by section, so you can see exactly how this would read for your own sites.

Executive summary and prioritized action plan
The part quality leadership acts on. Findings ranked high, medium and lower priority, each tied to the evidence behind it.
Inspection risk and CAPA robustness
Inspection history, a peer heatmap 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 a readiness 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.