Aligntra reads your procedures, records and your suppliers’ documents against the applicable standard and cites each nonconformity to the page and paragraph. Your auditor keeps the verdict. Nothing is sampled.
Verification plans must set out the methods, the acceptance criteria and, where appropriate, the statistical techniques and the rationale for sample size.
Each finding names the clause, the file and the page, states what falls short and why, and quotes the passage it was read from, verbatim. The classification stands only once your auditor confirms it.
Once a corrective action has run its course, its effectiveness has to be reviewed to confirm it did the job.
Your eQMS holds the record: versioning, routing, approvals, signatures. Aligntra never touches that. Below is what comes back when the reading is done, three ways.
| Your eQMS’s audit module | Reading it yourself | Aligntra | |
|---|---|---|---|
| How much gets read | What you point it at | A sample. You choose the percentage | Nothing is sampled. Each mapped document, in full, against the clauses it is expected to satisfy |
| Where a finding points | To a document, and a clause number | To wherever your notes say | To the page, the paragraph and the position on it, highlighted in the source PDF |
| How the clause is worded | However the vendor wrote it | Your own copy of the standard | The standard’s own words, taken from the published text |
| How a finding is graded | A status and a priority | You decide, at the end | Major NC, minor NC, observation or OFI, per ISO 19011, before you open it |
| Your suppliers’ documents | Scorecards, and the self-assessment they send back | You visit, or you trust the questionnaire | Read the same way as your own, through a link the supplier opens without an account |
| What it changes in your QMS | It is your QMS | Nothing | Nothing. No migration, no Part 11 scope, nothing to rip out |
Up to 50 at a time, in the format they are held. SOPs, procedures, records and supplier documents. No migration, no re-authoring, no naming convention to adopt.
Each document is mapped to the clauses it is expected to satisfy and read in full. Findings arrive unreviewed. An auditor confirms, dismisses or reclassifies each one, and the record retains both the citation and the decision.
The record stands without access to Aligntra. Coverage, findings and the readiness verdict export to Excel, PDF and JSON for the audit file, citations intact; the marked-up PDF highlights findings in the source document.
The mechanics do not change. Documents are read against the applicable standard and each nonconformity is cited to the page. What changes is who reads the result, and against what deadline.
Your own QMS on your own schedule
Their documents before you travel
Your own QMS before the registrar
The audit above ran against ISO 13485. The full table, with clause trees, is on the standards page.
| Standard | Revision | Domain | Auditable clauses |
|---|---|---|---|
| ISO 9001 | 2015 | Quality management | 235 |
| ISO 13485 | 2016 | Medical devices | 292 |
| AS9100D | 2016 | Aerospace | 328 |
| FDA QMSR | 21 CFR 820 · 2026 | Medical devices · US | 302 |
| EU MDR* | 2017/745 | Medical devices · EU | 266 |
| MDSAP* | AU P0002.010 | Five jurisdictions | 90 tasks |
| ISO 14971* | 2019 | Risk management | 133 |
| ICH Q10* | 2008 | Pharmaceutical quality system | 58 |
| ICH Q7* | 2000 | API GMP | 350 |
* In beta: indexed in full and available for analysis, and not yet through the promotion gates the four live standards have passed.
Working to a standard that isn’t here? Tell us which one. Requests are the primary input to our indexing roadmap.
Plans are published, with no per-seat charges and no implementation fee. Start with a first audit. An analysis is one document analyzed.
14-day trial: one audit, fifteen documents, exports included.
Security and data handling. Documents are encrypted in transit and at rest, never used to train any model, and scoped to your organization. Security questionnaires and a DPA are available on request. Aligntra produces cited evidence for your auditors to confirm. It does not replace your eQMS and is not a system of record.
Read the security page29 documents, 36 findings, each cited to the page. Open without an account.
