Five ISO standards and one automotive QMS in a single workspace for gap diagnosis, document generation, compliance review and calculators
FDA warning-letter and enforcement intelligence delivered as a daily brief
Stage
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Pricing model
Freemium
Freemium
Pricing
Not given
Starter: free. Professional: $49/month. Enterprise: $199/month. Annual plans available at 20% discount. Payment via card (Polar or Lemon Squeezy) or crypto (USDT, USDC, SOL via xpayr). Cancel anytime.
Key features
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
Filter by product type (device, drug, biologics, food, tobacco)
Company watchlists with instant notifications
Same-day alerts (Professional and Enterprise plans)
Searchable historical archive back to 2022
Email and Telegram delivery
CSV and API export
Customizable daily or weekly briefing schedule
API access and webhooks (Enterprise)
Slack and Teams delivery (Enterprise)
Multiple user seats (Enterprise)
What makes it different
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
Data normalized and classified from official FDA sources daily
Briefing designed to be scanned in 60 seconds
Precision filtering eliminates irrelevant alerts
Highest ROI for CDMO/CMO business development teams
LabKitPro