Documentation problems that lead to audit findings
Documents exist but don't cover requirements
You have SOPs for everything. But do they actually address the specific requirements of ISO 13485 clause 7.5.6 or AS9100D section 8.1.3? Having a document and having a compliant document are different things.
Revision drift creates hidden gaps
Documents get revised, processes change, and requirements evolve. Each revision can introduce new gaps or remove previously compliant content. Without re-verifying after every change, gaps accumulate silently.
Records don't match procedures
Your SOP says one thing. Your filled records show something different. CAPA timelines don't match documented deadlines. Training records don't demonstrate the competencies your procedures require.
Supplier documentation is a black box
You receive supplier quality manuals and SOPs but don't have the bandwidth to verify them against your standards. They sit in a folder until an auditor asks.
Every document type in your QMS
SOPs
Standard operating procedures verified clause-by-clause
Quality Manuals
Top-level QMS documents mapped against every clause
Work Instructions
Detailed process docs checked for requirement coverage
CAPA Records
Verified against SOP timelines, fields, and effectiveness
Training Records
Checked against competency requirements in procedures
Supplier Documentation
Supplier QMS docs analyzed with the same rigor as your own
How teams use Aligntra for documentation management
Document compliance verification
Upload individual SOPs or your entire document set. Get a report showing which clauses each document addresses, how well it covers the requirements, and where specific content is missing.
Record vs. procedure verification
Upload a procedure (SOP) and its filled records together. Aligntra verifies that records follow the documented process — checking timelines, required fields, approval sequences, and evidence of completion.
Post-revision re-verification
After revising a document, re-run the analysis to ensure the revision didn't introduce new gaps. Verify that updated content still addresses the same regulatory requirements.
Need to create new QMS documents?
Use Aligntra's SOP Builder to generate compliant SOPs, work instructions, and quality manuals tailored to your industry and standard. Turn a 2-week writing project into a 2-hour review and customization task.
Learn about SOP BuilderVerify documents against any standard
ISO 13485
Medical device QMS
Full SupportFDA QMSR
US medical device regulation
Full SupportAS9100D
Aerospace QMS
Full SupportISO 9001
General QMS
Full SupportEU MDR
European medical devices
Full SupportMDSAP
Multi-market device program
Full SupportISO 14971
Risk management
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