Help Center

Click "Start Your Trial" on our homepage or go directly to the app at aligntra.com. Enter your email, create a password, and you're ready to start. No credit card required for your 14-day trial.

We support PDF, DOCX, and DOC files. Maximum file size is 10MB per document. For best results, ensure your PDFs are text-based (not scanned images). If you have scanned documents, we can enable OCR for Enterprise customers.

Individual documents typically take 1-4 minutes each depending on document size, and are analyzed in parallel—so your entire QMS can be processed in minutes, not weeks. You'll receive an email when analysis is complete, or you can watch the progress in real-time on your dashboard.

During upload, select your compliance standard from the dropdown (ISO 13485, ISO 9001, AS9100D, FDA QMSR, EU MDR, MDSAP, ISO 14971). Trial and Professional users can select 1 standard. Professional users can add additional standards for $199/standard/month. Business and Enterprise tiers include all standards.

Yes! Our multi-document workflow analyzes your entire document package simultaneously and identifies gaps and overlaps across documents. This is available on all paid plans.

Confidence scores indicate how certain our AI is about each finding. HIGH (90%+) means strong evidence found. MEDIUM (70-89%) means evidence exists but may need clarification. LOW (<70%) means weak or unclear evidence— review these carefully. All findings should be validated by your team.

From the audit results page, click the export menu to choose your format: Excel (detailed evidence matrices, gap analysis, source references), Executive PDF (4-page summary with GO/NO-GO verdict, blocker list, and estimated audit findings), or JSON (structured data for integration). All formats include confidence scores and are formatted for audit submission.

15 analyses during your 14-day trial, 1 Full QMS Audit (5 docs), AI-powered classification, 1 regulatory standard, and email support. Exports available on Professional and above. No credit card required. Cancel or upgrade anytime.

All new accounts start with a 14-day trial — 15 analyses, 1 Full QMS Audit (5 docs), AI classification, 1 regulatory standard. Exports unlock with Professional. No credit card required. For larger organizations, request a personalized demo and we'll walk you through how Aligntra fits your specific compliance needs.

Yes. Upgrade anytime—changes take effect immediately and you'll be prorated. Downgrade at the end of your current billing cycle. All your data is preserved when changing plans.

Professional: You'll be prompted to upgrade to Business or wait until next month. Business: Purchase additional analysis credits or upgrade to Enterprise for unlimited analyses.

No. We NEVER use your documents to train AI models. Your compliance data remains private and is only used to provide analysis services to you. See our Security Policy.

Data is stored on secure cloud infrastructure in the US (default) with encryption at rest (AES-256) and in transit (TLS 1.3). Enterprise customers can request EU data residency or dedicated instances.

Yes. Delete individual analyses anytime from your dashboard—data is permanently removed immediately. Close your account and all data is permanently deleted. We provide export before deletion.

Yes, with a shared responsibility model. Aligntra is built with validation controls aligned to GAMP 5 and FDA's Computer Software Assurance (CSA) guidance. We validate the software (1,070+ automated tests, AI hallucination detection, evidence traceability); you validate its use at your site through UAT and procedures. We provide documentation to support your qualification. Learn more →

Aligntra is a quality system support tool (GAMP 5 Category 4/5)—not a medical device or SaMD. It assists qualified personnel with compliance review but does not make autonomous decisions. All AI findings require human review and link to exact source document locations for verification.

Every AI finding goes through: (1) Hallucination detection—semantic alignment checks verify evidence exists in the source document, (2) Confidence scoring—multi-factor scores flag uncertain findings, (3) Evidence traceability—every finding links to exact page, paragraph, and quoted text so you can verify against the original.

Partial. We have access controls (Clerk RBAC), organization isolation, and basic audit logging. For full Part 11 compliance with tamper-proof audit trails, contact us about enterprise capabilities. We provide a Part 11 compliance matrix showing shared responsibilities.

We provide: Validation Summary (testing evidence, AI controls, shared responsibility model), 21 CFR Part 11 Compliance Matrix, Release Notes, and Security Documentation on request. Contact validation@aligntra.com to request documentation.

Your responsibilities include: (1) Determine intended use for your processes, (2) User Acceptance Testing (UAT), (3) SOPs for how your team uses Aligntra, (4) User training on AI limitations, (5) Human review of all AI findings, (6) Final compliance determinations by qualified personnel.

Yes! API access is available on Professional, Business, and Enterprise plans. Use our REST API to submit documents, retrieve results, and integrate with your QMS. Contact us for API documentation and onboarding.

Yes. Aligntra is designed to complement—not replace—your QMS. Use our API to send documents from your QMS for analysis, then import results back. We also support Google Drive integration for importing documents directly from your cloud storage.

Connect your Google Drive account via OAuth, then browse and import documents directly into Aligntra—no manual download/upload required. Aligntra requests read-only access and encrypts stored connection tokens. Available on all tiers.

Yes. In Full QMS Audit, you can select your target standard and analyze your entire document package against it. Trial and Professional include 1 standard (+$199/standard add-on on Professional). Business and Enterprise include all 9 supported standards.

Yes. Once you start an analysis, you'll see a live progress dashboard showing each document's status, the current analysis phase, and estimated completion. Progress updates are delivered in real time via WebSocket—no need to refresh.

Most documents complete in 1-4 minutes. If stuck longer than 15 minutes, refresh your browser. Still stuck? Contact support@aligntra.com with your analysis ID.

Low scores may indicate: (1) vague or incomplete documentation, (2) requirements not explicitly addressed, or (3) document quality issues (scanned PDFs, poor formatting). Review flagged sections and improve documentation clarity. Our AI is designed to be conservative—better to flag potential gaps than miss them.

Our system uses multi-layer validation including hallucination detection, confidence scoring, and evidence traceability to maintain high accuracy. If you find incorrect links, please contact support@aligntra.com. You can manually adjust evidence references before exporting.

Check: (1) File size under 10MB, (2) Format is PDF/DOCX/DOC, (3) File isn't password-protected, (4) You haven't exceeded your monthly analysis limit. Still having issues? Try a different browser or contact support.