Rehearse the inspection with experts who know what the inspectors will ask.
The readiness document review settles the paperwork first, so the days on site go to what only a person on the floor can judge.
Records can be in good order and the site can still come apart under questioning. Does the operator describe the deviation the way the batch record implies? Can the QA lead defend a CAPA closure out loud, without notes? Does the room tell the same story as the SOP? None of that is visible in a document set.
Because the readiness document review has already mapped what your records show, the on-site days are not spent reading. They are spent on the human layer: how your people answer, how the floor actually runs, and how the two line up.
An inspection is expected
You have notice, or your risk profile says you are near the top of the list, and you want one full rehearsal before it counts.
Pre-approval inspection
A product filing puts a specific line and a specific set of validation packages under the spotlight for the first time.
Post-483 remediation
Commitments have been made in writing. A mock inspection puts those commitments to the test in practice, before the inspectors return to check them.
A new authority
You are entering a market whose inspectorate you have never hosted, and you want to know how its expectations differ from the ones you know.
Inspected against the expectations of the inspectorate you expect, not a generic GMP standard.
The chapters are broadly shared. The emphasis is not. The same site can be comfortable under one inspectorate and exposed under another, because each brings its own line of questioning, evidence threshold and tolerance for a weak investigation. We scope the mock inspection to the inspectorate in view.
An auditor who is already in your country, and already speaks the language of your floor.
Qualifyze runs roughly 250 onsite audits every month across 80+ countries with a network of 400+ qualified auditors. For a mock inspection that means three practical things.
Scheduled in weeks, not quarters
Local coverage removes the travel and visa lead time that usually decides when a mock inspection can happen at all.
Conducted in the local language
Operators are questioned in the language they actually work in, so the answers reflect what they know rather than what they can translate.
Familiar with local practice
Auditors who regularly host the regional inspectorate know how it opens, what it escalates, and where it tends to dig.
The findings, and the evidence behind them.
Inspection findings report
What we observed, written the way an inspector would raise it, with the evidence behind each observation set out so your team can verify it themselves.
Prioritized findings
Observations ordered by how material each one is to an inspection outcome, separating what needs to close from what can reasonably be shown as in progress.
Follow-up discussion
A session once your team has read the report, to walk through what was observed and why it was raised, so nothing is interpreted cold.
Confidential to you. A mock inspection is never shared with regulators or with your customers, and is walled off from any Qualifyze third-party audit of your site.
One of three ways we keep you inspection-ready.
Quality Insights Platform
Ongoing quality-risk assessment across your own and your supplier sites, so the risk picture is current between inspections.
Explore the platform →Inspection Readiness document review
A confidential documentary review of the SOPs, validation and quality documents and KPIs you already hold, returned as a prioritized map of your gaps.
See the readiness document review →Mock Inspection
A full on-site rehearsal against the expectations of the inspectorate you expect, with a findings report and a follow-up discussion.
You are hereFind out how your site would hold up, while you can still do something about it.
Thirty minutes to scope the authority in view, the systems that matter and the timing. No site data required to book.
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