REGULATORY QMSR replaces 21 CFR Part 820 — is your quality system ready? Check your gaps free →
Pricing

Simple, transparent pricing

Start your 14-day trial. Scale as your audit volume grows. No hidden fees.

Why subscription pricing? A single manual compliance review costs $2,500+ in loaded labor. One subscription month lets you review your entire QMS, all your suppliers, and run unlimited re-checks — for less than a single manual review.

How much could you save?

We run approximately compliance audits per month
That's roughly 60 documents reviewed manually — costing around $5,000/mo in labor. Aligntra starts at $499/mo, a potential savings of $4,501/mo.
See full ROI breakdown →
Monthly
Annual

Get Started

14-Day Trial

$0 for 14 days

Full access to try Aligntra risk-free for 14 days. No commitment — cancel anytime.

  • 15 analyses
  • 1 Full QMS Audit (up to 5 docs)
  • 1 regulatory standard
  • AI-powered document classification
Start Your Trial

Solo QA Consultant

Professional

$499 /mo (billed annually) Save 33%

Run up to 2 full compliance audits per month with evidence traced to exact page and paragraph.

  • 60 analyses per month
  • Excel & PDF export
  • 1 regulatory standard (+$199/standard • all standards with Business)
  • Evidence traceability + PDF highlighting
  • Priority email support (24hr response)
  • 1 user seat
Start Your Trial or book a demo

Multi-Site Organizations

Enterprise

Custom

For large companies, notified bodies, and complex multi-standard compliance requirements.

  • Unlimited analyses across all standards
  • Custom standards & frameworks
  • SSO/SAML & API access
  • SLA guarantee & dedicated CSM
  • Custom onboarding, training & data residency
  • Audit trail & compliance logging
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Compare plans

Feature comparison across pricing plans
Feature Trial Professional Business Enterprise
Analysis
Analyses per month 15 (14 days) 60 150 Unlimited
Regulatory standards 1 1 (+$199/ea) All All + custom
Evidence traceability Included Included Included Included
PDF evidence highlighting Not included Included Included Included
Full QMS Audit 1 (5 docs) Included Included Included
Record Compliance Verification (RCV) Not included Included Included Included
Export & Reporting
Excel export Included Included Included Included
PDF reports Included Included Included Included
White-label reports Not included Not included Included Included
Team & Support
User seats 1 1 5 (+$99/seat) Unlimited
Support response 72 hours 24 hours Priority + chat Priority + chat
Dedicated CSM Not included Not included Not included Included
SSO/SAML & API access Not included Not included Not included Included
SLA guarantee Not included Not included Not included Included
Custom onboarding Not included Not included Not included Included

Questions & Answers

What counts as an "analysis"?

Each document you upload and analyze counts as one analysis toward your monthly limit. Re-analyzing the same document uses cached results and does not count again.

What regulatory standards do you support?

Aligntra supports ISO 13485, FDA QMSR (21 CFR Part 820), ISO 9001, AS9100D, EU MDR, MDSAP, and ISO 14971. Enterprise plans can include custom standards and frameworks tailored to your industry.

How does this compare to manual audits?

A manual compliance review typically costs $2,500+ in loaded labor and takes days to weeks. Aligntra delivers findings in minutes with evidence traced to exact page and paragraph — at a fraction of the cost.

Is my data secure?

Yes. All documents are encrypted in transit and at rest. We use enterprise-grade cloud storage with organization-level isolation — your data is never shared across accounts or used to train AI models.

Can I switch plans anytime?

Yes. Upgrade or downgrade at any time. When upgrading, you get access immediately. When downgrading, the change takes effect at the end of your current billing period.

Is there a free trial?

Yes. All new accounts start with a 14-day trial that includes 15 analyses, Full QMS Audit, and AI classification. No commitment — cancel anytime during your trial. When you're ready for more, upgrade to a paid plan.

Do you offer discounts for annual billing?

Yes. Annual billing saves up to 33%. Professional is $499/mo annual vs $749/mo monthly. Business is $1,249/mo annual vs $1,699/mo monthly. Use the toggle above the pricing cards to compare.

What happens if I exceed my analysis limit?

You'll receive a notification when you're approaching your limit. Once reached, you can wait until next month or upgrade your plan to continue analyzing.

Ready to get started?

Start your 14-day trial. No commitment — cancel anytime.

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