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Taktly

CI projects don’t fail in planning. They fail in execution.

The MBB-grade execution engine for CI / OpEx / Quality teams.

gettaktly.com

30-second senior review

Drop a charter, A3, CAPA, RCA, business case, or full DMAIC. Get a scored audit with rewrites, FDA Warning Letter pattern matches, and a 5-reviewer panel. Free, no signup.

Devil's Advocate + FMEA

Adversarial review on every confirmed root cause. FMEA / RPN scoring on every Improve action. Containment / Corrective / Preventive separation enforced per ISO 9001 / 21 CFR 820.

Taktly Watch (post-closure)

After Control closes, Watch reads the verification metric and flags drift. The Sustainment dashboard rolls up every closed project: holding / drifting / regressed.

Financial savings model

Baseline × target × volume × cost-per-event = annualized hard savings with a low / point / high sensitivity band. Server-recomputed on every blur.

What runs inside

  • • Cp / Cpk / σ-level / DPMO on every dataset (AIAG SPC, 1.5σ shift)
  • • Sample-size + power on every verification window (one- / two-sample / proportion)
  • • FMEA / RPN on every countermeasure (S × O × D, mitigation required at RPN ≥ 120)
  • • FDA Warning Letter pattern library (paraphrased real 483s, industry-tagged)
  • • 5-reviewer panel — MBB / FDA reviewer / CFO / plant manager / sponsor
  • • Phase Bridge cards + coherence detection (17 pure-function checks)
  • • Auto-fire countermeasures on RCA verdict flip; auto-fire Devil’s Advocate on import
  • • Deep import: hypotheses, 5-Whys, countermeasures, verifications all populate from a PDF

Graded against

21 CFR 211 · 21 CFR 820 · ICH Q7 · ICH Q9 · ICH Q10 · EU GMP Annex 1 · ISO 13485 · ISO 14971 · ISO 9001 · IATF 16949 · AS9100 · FSMA · HACCP · USDA FSIS · GFSI (BRCGS, SQF, FSSC 22000)

For teams in

Pharma · Biotech · Fill-finish · Vaccines · Cell & gene therapy · API / fine chemicals · Plasma · CDMOs · Medical Device (Class II/III, IVDs, combination products) · Food & beverage · Ingredients · Co-manufacturing

Free tier

$0

Public audit, no signup. 3 audits/wk for signed-in free users.

Practitioner

$149/mo

Unlimited audits + clean PDFs + Watch. Founder pricing.

Pro · 5 seats

$7,500/yr

Full engine + Devil’s Advocate + FMEA. Founder pricing.

Try it

gettaktly.com — 30 seconds, no signup, your data stays in your tenant.

Methodology: gettaktly.com/methodology · Compare: gettaktly.com/compare · ROI: gettaktly.com/roi