Choose Your Path
Different roles have different compliance challenges. See how Aligntra addresses yours.
QMS Consultants
Scale your practice without scaling headcount
The Challenge
You're juggling multiple clients across different standards. Each gap assessment means days of manual document review. You want to take on more clients, but there aren't enough hours in the day. Meanwhile, clients expect faster turnaround at competitive rates.
How Aligntra Helps
Run comprehensive gap assessments in hours instead of days. White-label reports let you deliver professional deliverables under your brand. Each client gets their own secure workspace — switch between clients and standards instantly.
- White-label reports - Your branding, our analysis
- Client isolation - Each client gets their own secure workspace
- All standards included - ISO 13485, AS9100D, FDA QMSR, EU MDR
- Audit-ready exports - Excel and PDF with evidence citations
Small & Medium Manufacturers
Enterprise-grade compliance without the enterprise budget
The Challenge
Your quality team wears many hats. Audit prep pulls people away from production and product development. Hiring a consultant for every assessment isn't sustainable, but neither is the anxiety of wondering if you've missed something critical before your next audit.
How Aligntra Helps
Get the analysis depth of an experienced consultant at a fraction of the cost. Run self-assessments anytime to catch gaps before auditors do. Our platform guides you through exactly what auditors look for, so you know where to focus your limited resources.
- Predictable pricing - Know your costs upfront, no surprises
- Plain-English findings - Clear guidance, not auditor jargon
- Self-service assessments - Run checks anytime without scheduling
- Supplier verification - Check supplier docs before problems hit
Enterprise Manufacturers
Compliance at scale with full visibility
The Challenge
You operate across multiple sites, standards, and regulatory jurisdictions. Keeping compliance status consistent across the organization is a constant battle. Different teams use different methods, making it hard to get a unified view of audit readiness across the enterprise.
How Aligntra Helps
Standardize compliance assessment across your entire organization. Apply the same analytical rigor to every facility and every supplier. Import documents from Google Drive, run analyses against all supported standards, and export audit-ready reports for leadership review.
- Team workspaces - Role-based access with shared audit history
- Google Drive import - Connect your existing document storage
- All 7 standards included - ISO 13485, FDA QMSR, AS9100D, ISO 9001, EU MDR, MDSAP, ISO 14971
- Priority support - Direct access to the engineering team
Regulatory Agencies & Notified Bodies
Accelerate assessments with intelligent pre-screening
The Challenge
The volume of submissions keeps growing while the pressure to reduce assessment timelines intensifies. Your auditors spend too much time on initial document review that could be better spent on high-value technical evaluation. Consistency across assessors is difficult to maintain.
How Aligntra Helps
Use intelligent pre-screening to quickly identify submissions that need deeper review. Standardize initial assessment criteria across your team. Generate preliminary gap reports that your auditors can use as a starting point, reducing time to first findings and improving consistency.
- Pre-screening automation - Triage submissions faster
- Standardized criteria - Consistent assessment across auditors
- Full audit trail - Every finding linked to source evidence
- Volume licensing - Pricing that scales with your needs
By Capability
Explore what Aligntra does — regardless of your role or industry.
Compliance Assessments
Gap assessments, internal audits, and audit preparation — one tool for all three workflows. Clause-by-clause findings with evidence citations.
Core CapabilityQMS Documentation
Verify your SOPs, quality manuals, and records actually meet standard requirements. Plus document library and SOP Builder.
Common Use Cases
See how teams like yours use Aligntra every day
Supplier & Vendor Audits
Verify supplier QMS documentation before onboarding and during periodic reviews. Reduce supply chain compliance risk with consistent, evidence-based audits.
Vendor Qualification
Qualify new vendors faster by automating document review. Ensure suppliers meet ISO 13485, AS9100D, or FDA QMSR requirements before you commit.
Internal Gap Assessments
Use the same tool for your own QMS self-assessments. Run internal gap analysis 4-6 weeks before certification audits.
Continuous Monitoring
Re-analyze supplier or internal documents after updates to ensure changes haven't introduced new gaps. Catch drift before it becomes a finding.
Due Diligence
Quickly assess compliance status of acquisition targets. Identify regulatory risks that could affect deal value.
Post-Audit Remediation
After fixing audit findings, verify your corrective actions actually address the gaps. Don't wait for the next audit to find out.
Ready to Transform Your Compliance Workflow?
Run gap assessments in hours instead of days. Start your 14-day trial today or talk to our team about your specific needs.