Product

The platformDocument intake, clause analysis, evidence review, adjudication and export Record verificationCAPA and NCR records verified against your own procedures How it worksFull-document reading, page-level citations, auditor adjudication SOP Builder early accessProcedure drafting aligned to your standard

Solutions

Internal auditsAudit of your own quality system documents Supplier auditsSupplier documentation audited against your standard Certification prepPre-assessment against the standard before a registrar audit Medical devicesISO 13485 · FDA QMSR · EU MDR · ISO 14971 AerospaceAS9100D · ISO 9001 PharmaceuticalICH Q10 · ICH Q7 ManufacturingISO 9001 ConsultingClient engagements across all nine standards

Resources

Audit checklistsFree, one per standard, with auditor guidance InsightsField notes on audits and regulatory change See a sample auditThe published example QMS in sequence StandardsCoverage and clause counts for all nine ServicesConsulting — we do the work and the re-run proves it Pricing Sign in Request a demo

Early access — not yet released

SOP Builder

It is a second product, still in development, that drafts quality-system procedures against the clauses they have to satisfy.

One email, when there is something to try. We do not send a newsletter.

Available now

Aligntra audit

Reads the procedures and records you already have against the applicable standard, and reports nonconformities with the page and paragraph cited.

See a sample audit

In development

SOP Builder

Drafts a procedure against the clauses it has to satisfy. You own and edit the result.

Where it is today

SOP Builder is built but not verified. It is not on sale, it is not part of any plan, and there is no price for it — anything we published now we would have to take back. Leave an email and we will write once, when it is ready to try.