The platform
Clause-level audit of quality system documents.
Aligntra reads each mapped document in full against the clauses it is expected to satisfy. Findings cite the source page and paragraph, are adjudicated by your auditor, and are exported as the audit record.
Nine standards · PDF, DOCX and XLSX · Findings graded per ISO 19011
Method
Three properties of the audit.
Each mapped document is read in full against each clause in scope. Coverage is reported per clause.
CAPA and NCR records are verified against each requirement of the governing SOP, in the same audit run.
Each finding is confirmed, dismissed or reclassified by your auditor. Dismissed findings are excluded from the exported record.
Upload and classify
Documents are accepted as PDF, DOCX and XLSX, up to 50 per upload, in their existing format. Each document is assigned a type (procedure, record, policy or work instruction) and mapped to the clauses it is expected to satisfy. The mapping can be reviewed and corrected before analysis runs.
Analysis of documents and records
Two layers run in the same audit. Procedures, policies and work instructions are read against the standard. Records are checked against the procedure that governs them.
Layer 1 · documents against the standard
Each mapped document is read in full against each clause in scope, for any of nine supported standards. Findings are graded per ISO 19011 as Major NC, Minor NC, Observation or OFI. Clauses not yet covered by any document are reported as not assessed.
The example QMS · coverage by clause
Layer 2 · records against your procedures
A CAPA or NCR record is checked against each requirement of the SOP that governs it. The procedure is the reference for a record. Available for CAPA and NCR records. Record verification →
The example QMS · a CAPA SOP requirement used to verify a record
Evidence and citations
Each finding cites its source document, page and paragraph. Opening a citation displays the source page with the cited passage highlighted, next to the finding it supports. Findings without supporting evidence are not produced.
Adjudication and export
Each finding carries a review state and can be confirmed, dismissed or reclassified by severity. Dismissed findings are excluded from the export. The audit record is exported with citations and verdicts included.
The audit workspace
Each audit opens as one workspace with eight views.
The run produces one audit. Its views hold the readiness verdict, coverage, documents, findings, records, remediation plans, the document network and the exports.
| View | Contents |
|---|---|
| Summary | Readiness verdict, coverage and findings by severity for the audit. |
| Coverage | Each clause in scope with its standing, including clauses not yet assessed. |
| Documents | Each file with its assigned type, mapped clauses and analysis status. |
| Issues | Findings grouped by clause and severity, each with its review state. |
| Records | CAPA and NCR records verified against the procedures that govern them. |
| Remediation | Remediation plans for confirmed findings on procedures. |
| QMS Map | The document network: which documents reference which. |
| Exports | Excel workbook, annotated PDF and JSON, each including citations and verdicts. |
The example QMS audit is published in full.
Review the completed audit, then request a demo with your own documents.