| Key features | - Connect and sync source documents across SharePoint, Box, Google Drive, and other systems
- Real-time submission readiness tracking combining validation findings, drafting progress, and risk signals
- Automated deadline-driven workflows with validation, drafting, routing, and readiness checks at T-30, T-14, and T-3
- 21 CFR Part 11 and EU Annex 11 compliant audit trails with role-based access
- eCTD structure, lifecycle, and metadata validation before submission
- eSTAR completeness, evidence packaging, and filing readiness validation for medical devices
- Multi-jurisdiction coordination with FDA, EMA, and Health Canada workflow support
- Sponsor isolation controls for CROs with separate document storage, access controls, and audit trails per sponsor
- Sponsor read-only dashboard for real-time program status and readiness scoring
- Repeatable workflows and pre-configured templates for rapid sponsor onboarding
| - 60-second gap diagnosis with heat-map
- Document generation for manuals, procedures and forms
- Clause-by-clause compliance self-audit
- Measurement uncertainty calculator with GUM and Monte Carlo methods
- SPC control charts, MSA Gage R&R and process capability calculators
- AIAG core tools including FMEA and PPAP for automotive
- Environmental aspect and JHA/JSA risk matrices
- Compliance calendar, CAPA tracker and document register
- Integrated documentation for 9001, 14001 and 45001
- 2026 and 2029 transition packs for edition updates
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| What makes it different | - Recovers 100+ hours and avoids $150-250K in rework and filing delay costs per submission
- Reduces eCTD and eSTAR defects before filing through continuous validation during drafting
- Eliminates version drift and manual status reporting with shared comments and real-time traceability
- Standardizes CRO workflows across multiple sponsors without per-sponsor customization
- Enables lean teams to handle 3x more submission capacity without expanding headcount
| - All calculations and basic diagnosis are free with no sign-up required
- One shared context across five standards eliminates duplicate work
- Every generated item cites its standard clauses for auditability
- User data stays local in browser; no files sent to servers
- Not a certification body, so purely advisory preparation without audit authority
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Assyro AI
LabKitPro