Scale creates compliance complexity
"Each facility interprets standards differently. Without a consistent methodology, I can't compare compliance status across sites — gaps at one facility become surprises at another."
"By the time we aggregate compliance data across sites, it's already stale. We need visibility that doesn't require weeks of manual rollup."
"Hundreds of suppliers, each with their own QMS documentation. We don't have the bandwidth to verify every supplier document thoroughly — so gaps slip through."
"Regulatory, customer, and internal audits consume thousands of team-hours annually. My best people spend more time preparing for audits than improving the QMS."
What changes with Aligntra
| Before Aligntra | After Aligntra |
|---|---|
| Weeks of manual aggregation to see compliance status across sites | Same-day per-site results with consistent methodology |
| Months to verify supplier portfolio — one supplier at a time | Batch-analyze supplier documentation in hours |
| Each site improvises their own audit prep process | Every site runs the same analysis with comparable results |
| Separate tools and consultants per standard | All 7 standards on one platform — switch instantly |
Built for organizational scale
All 7 standards included
Business and Enterprise tiers unlock every supported standard — ISO 13485, FDA QMSR, AS9100D, EU MDR, MDSAP, ISO 9001, and ISO 14971. No per-standard add-ons or hidden fees. Switch between standards instantly for any document set.
Team workspaces
Role-based access with shared audit history. Each site manages their own documents while corporate QA maintains visibility.
Consistent methodology
AI applies the same analytical rigor across every site, every time. Results are comparable because the methodology is identical.
Executive reporting
Exportable summaries formatted for leadership. Demonstrate continuous improvement to stakeholders.
Every standard your organization needs
All standards included on Business and Enterprise tiers — no per-standard fees
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
Full SupportReady to standardize compliance across your organization?
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