Compliance challenges you know too well
The Challenge
FDA 483 observations from documentation gaps. Inspectors find what manual reviews miss — incomplete document control, missing traceability records, CAPA gaps.
With Aligntra
Clause-by-clause analysis catches what manual reviews miss. Every finding links to the exact page and paragraph so you can verify and fix before the inspector arrives.
The Challenge
2-4 weeks of audit prep before notified body visits. Your quality team pulls documents, cross-references clauses, builds binders — time taken from product development.
With Aligntra
Upload your QMS documents and get a complete compliance picture in minutes. Your team spends time fixing gaps, not finding them.
The Challenge
CAPA records that don't match your SOPs. Manual verification takes hours per record — timeline compliance, required fields, evidence of effectiveness review.
With Aligntra
Upload a CAPA SOP and its records. Aligntra extracts requirements and verifies each record automatically — including timelines, fields, and effectiveness evidence.
The Challenge
50+ suppliers on your AVL, each with their own QMS documentation. You need to verify compliance for onboarding, periodic reviews, and audit findings. Manual review doesn't scale.
With Aligntra
Upload a supplier's quality manual and get a gap report with evidence citations in minutes. Verify 50 suppliers in the time it used to take to review one.
5 standards. 2,400+ clauses. Full coverage.
Every standard your auditor checks — analyzed clause by clause with evidence traceability
Audit your supply chain at scale
Most medical device companies audit supplier QMS documents manually — or skip it until something goes wrong. Aligntra lets you run the same depth of analysis on supplier documents that you run on your own. Upload a supplier's quality manual, get a gap report with evidence citations, and make data-driven qualification decisions. No travel. No scheduling. No waiting for consultant availability. Verify 50 suppliers in the time it used to take to review one.
How medical device teams use Aligntra
Supplier QMS audits
Upload a supplier's quality manual, SOPs, or records. Get a clause-by-clause compliance report against ISO 13485 or FDA QMSR in minutes.
Pre-audit gap analysis
Run the same analysis 4-6 weeks before your notified body visit. See which clauses are covered, partially addressed, or missing entirely.
CAPA record verification
Upload a CAPA SOP and its records. Aligntra verifies timeline compliance, required fields, and evidence of effectiveness review.
Multi-standard readiness
Analyze against ISO 13485 + FDA QMSR + EU MDR simultaneously. See where documentation satisfies all standards independently.
Built for medical device compliance
"I link every finding to the exact page, paragraph, and text in your source documents. Click any citation to see it highlighted in the built-in PDF viewer."
"I reduce 70-80% of redundant findings. Instead of 200 individual gaps, you see 40-50 consolidated findings grouped by clause with remediation guidance."
"I score each clause based on evidence quality and coverage. See at a glance which sections need attention before your audit — your own QMS or a supplier's."
"I analyze up to 30 documents in parallel for system-level compliance. Every clause mapped, every gap cited, audit-ready summary — in approximately 4 minutes."
Ready to automate your medical device compliance?
Start your 14-day trial. Analyze your own QMS or audit supplier documents in minutes.
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