Release Notes
Track updates, new features, and improvements to Aligntra
Unreleased
#
Coming Soon
- SOP Builder pricing tiers and self-service checkout
- Public API for third-party integrations
- Enhanced analytics dashboard with trend charts
New Features
- Full QMS Audit: Analyze your entire Quality Management System across multiple documents at once, with coordinated gap detection and audit readiness scoring
- SOP Builder: Generate audit-ready Standard Operating Procedures with AI assistance — includes verification, DOCX export, and per-package pricing
- Document Library: Centralized hub to manage, classify, and organize all your compliance documents with vendor linking
- Google Drive Integration: Import documents directly from Google Drive for faster analysis
- Executive Summary Export: Download professional PDF and Excel reports with ISO 19011 gap tables, blocker lists, and estimated audit findings
- Gap Consolidation: Smart deduplication reduces duplicate findings by 70-80%, grouping related gaps by clause for cleaner reports
- Real-Time Analysis Progress: Watch your analysis run live with WebSocket-powered progress updates, phase indicators, and per-document status
- Audit Readiness Score: Get an overall score showing how prepared you are for audit across all documents and clauses
- Smart Finding Organization: RCV findings are now grouped by process phase (Investigation, Action, Verification, etc.)
- Onboarding Checklist: New users get a guided checklist and interactive tour to help get started quickly
- Compilation Reports: Group multiple analyses into a single executive report for management review
Improvements
- Better visual presentation of RCV results with enhanced evidence quality indicators
- Validation page now has color-coded indicator bars for easier review
- Improved email notifications with better formatting across email clients
- More accurate evidence linking to exact document locations
- Document deduplication detects duplicate uploads by content hash before analysis
- Parallel analysis processes up to 6 documents simultaneously for faster audit completion
Bug Fixes
- Fixed issue where multi-document analysis results weren't displaying completely
- Validation page scrolling and collapsing now works smoothly
- Documents with unknown classification now prompt you to select manually
- Mobile menu now opens correctly on all devices
- Login and authentication flows are more reliable
New Features
- CAPA Coherence Checks: Automatically verify that CAPA records are logically consistent across initiation, investigation, and closure
- Audit Risk Indicators: Identify and score potential audit risks in your records with severity ratings
- Subscription Billing: Manage your subscription and payments directly in the app via Stripe
- Vendor Assessment: Evaluate vendor CAPA systems for compliance with audit trail tracking
- Analysis History: Track and manage all your past analyses in one place with filtering
- Audit Questions in Exports: Excel exports now include auditor questions for easier preparation
- Cross-Document Verification: Link findings across related documents to identify traceability gaps
- ISO 19011 Issue Classification: Findings now categorized as Major NC, Minor NC, Observation, or OFI per ISO 19011 audit guidelines
- NCR Verification Plugin: Verify Non-Conformance Records against NCR SOPs with timeline compliance checks
Improvements
- Multi-document workflow now shows progress as analysis runs
- Better section selection when analyzing multiple documents
- Improved document classification accuracy
- Advanced notification system with email templates and user preferences
Bug Fixes
- Logout now works correctly across the entire app
- Multi-document analysis displays all results properly
- Better handling when API usage limits are reached
New Features
- Record Verification System (RCV): Complete workflow to verify quality records against SOPs
- Multiple Process Areas: Support for CAPA, NCR, Training, Document Control, and Complaint records
- Smart Section Matching: Automatically match documents to relevant ISO sections
- Document Deduplication: Detect and prevent duplicate document uploads automatically
Improvements
- More accurate evidence linking with better section detection
- Faster analysis with improved document processing
- Cloudflare R2 storage with circuit breaker for reliable document access
Bug Fixes
- Document Control SOPs no longer trigger false positives for unrelated clauses
- Multi-document workflow is more reliable
New Features
- Team Collaboration: Invite team members and collaborate within your organization
- Enterprise Authentication: Secure login with SSO support for enterprise customers via Clerk
- Role-Based Access: Assign roles (Owner, Admin, Member) to control who can do what
- Organization Management: Create and manage your organization with dedicated billing and usage tracking
- Audit List Pagination: Browse large audit lists efficiently with server-side pagination and search
Security
- Data is completely isolated by organization — you only see your data
- Enhanced credential management for enterprise security
New Features
- Industry-Specific Analysis: Specialized support for Medical Device, Pharmaceutical, and Aerospace industries
- Multiple Standards: Analyze against ISO 9001, AS9100D, FDA QMSR, EU MDR, MDSAP, and ISO 14971
- Extensible Architecture: Platform now supports custom process areas and industry modules via plugin system
Improvements
- More accurate analysis tailored to your specific industry and standard
New Features
- Evidence Linking: Every finding links to the exact location in your document (page, paragraph, character)
- Confidence Scoring: See how confident the AI is about each finding
- Quality Checks: Automatic verification to ensure findings are supported by evidence
- Coverage Analysis: Understand which sections are well-covered and which need more documentation
- Excel Export: Download professional compliance reports
Improvements
- Results now include precise source locations for easy verification
- Confidence scores help you prioritize review efforts
Initial Release
- Document Analysis: Upload a document and analyze it against ISO 13485
- AI-Powered Review: Clause-by-clause compliance analysis using advanced AI
- PDF Support: Extract and analyze text from PDF documents
- Web Interface: Simple upload and results viewing
- Fast Processing: Cached results for cost optimization