Skip the document review.
Spend the audit on what needs an auditor.
Aligntra reads every SOP, procedure, and record against the standard — paragraph by paragraph — so your hours go to the gaps, the sampling exceptions, and the calls only an auditor can make.
How we think an audit should work.
Five things we believe — and built the product around. Each one is a deliberate choice, not a feature roadmap.
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01
Every finding cites a paragraph.
No "this seems off." No "review section 7." When Aligntra flags a finding, the cited text opens in the PDF with the exact lines highlighted. You verify the AI the way you'd verify a junior auditor — by reading what they read.
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02
Sampling five records of two hundred isn't auditing.
ISO 19011 §6.4.7 names sampling risk explicitly because auditors have to sample — reading 200 CAPAs by hand takes a month. Aligntra reads every record in the audit. The math on systemic issues changes when the denominator is all of them.
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03
Minutes, not weeks.
A six-document audit completes in under five minutes wall-clock. Not "queued in five minutes." Not "results within 24 hours." Five minutes from upload to clause-by-clause readiness — so the loop closes the same morning you opened it.
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04
One platform, nine standards.
ISO 9001 · ISO 13485 · AS9100D · FDA QMSR · EU MDR · MDSAP · ISO 14971 · ICH Q10 · ICH Q7. Run the same QMS against any of them — and FDA QMSR coverage comes through ISO 13485 directly, because the regulation incorporates it. You don't pay three vendors to read the same SOP three times.
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05
Internal, supplier, certification — one model.
ISO 19011 recognizes three audit types. Most QMS tools serve one. A finding from your internal audit auto-surfaces during certification prep — same data, same evidence, same readiness math. Three audits, one record.
What Aligntra is not.
Clarity about what we don't do is usually more useful than another claim about what we do.
You keep the document system you already have.
MasterControl, Greenlight Guru, Veeva, SharePoint, a Google Drive — it doesn't matter. We're the read layer that sits on top.
GRC tools collect attestations. We read your documents.
"Confirm you have a CAPA SOP" isn't an audit. Confirming what your CAPA SOP actually says against the standard — that is.
We're the audit, not the rolodex.
No referral fees. No "talk to one of our partners." If you need a consultant after we run, that's a decision you make with the evidence in front of you.
We prepare you for the registrar's audit. We don't issue certificates.
The whole point is to know what the registrar will find before they walk in. We make the homework honest; they still grade the test.
Why this exists.
Three different audit jobs, one shared wall. Consultants bill by the hour and spend most of those hours reading documents. Internal auditors at regulated manufacturers are asked for 100% clause coverage on a one-week schedule. Supplier auditors are told to qualify ten new vendors a quarter when each one is a week of reading.
The eQMS market sells the document system. Then everyone pays again — in billable hours, in unpaid evenings, in audit scope cut to fit the calendar — for someone to read it. The reading is the actual hard part. The system is just where the documents sit.
Aligntra reads the documents. Your hours go to judgment — the gaps, the sampling exceptions, and the questions that need an auditor in the room.
A 30-minute audit on a real QMS.
Bring your own documents if you're ready, or we'll run it on a published example QMS we maintain.
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