Resources
Methodology, comparison matrix, ROI calculator, human-in-the-loop policy, the free FDA Warning Letter pattern library, and the software-category deep dives. One page. All the receipts.
Quick links
The 4-step product walkthrough with screenshots of each surface.
Open
The full receipts: deterministic detectors, LLM scoring calibration, FDA pattern library, MBB-grade engine layers.
Open
Taktly vs. Excel · Minitab · Veeva-SAP CAPA · KaiNexus. 18 honest rows.
Open
Single-project + portfolio mode. Same savings engine that runs inside every Taktly project.
Open
Taktly drafts. You decide. Six mechanisms that keep the human in charge.
Open
Paraphrased CAPA-inadequacy patterns FDA cites in Warning Letters, with the rewrite that would have passed.
Open
Software for the way you work
Taktly is purpose-built software for DMAIC projects. Phase gates from Define through Control. Charter, SIPOC, Measurement System Analysis, process map, root cause, hypothesis testing, countermeasure selection, control plan, and A3. Every tollgate is a one-click PDF export. Used by Black Belts, Master Black Belts, and CI managers running pharmaceutical, medical device, food, and general manufacturing DMAIC projects.
Taktly's Lean workspace is built for waste walks, value stream mapping, takt time analysis, future-state design, and Kaizen events. Cycle time, changeover, uptime, defect rate, and wait time are first-class fields on every VSM step. The 8-wastes walk (DOWNTIME) is structured and costed. Designed for Lean practitioners running continuous flow, 5S, and sustainment work on the Gemba.
For improvements that don't need full DMAIC rigor. Taktly's Process Improvement workspace follows PDCA in four phases with 5-Why analysis, pilot planning, confirmation runs, and sustainment tracking. Light-weight enough for a supervisor to run the first project; structured enough for a Green Belt to defend the result.
Taktly's Standard Work library gives every step a key point, reason, time, quality check, and safety watch-out. Training matrix tracks operator competency levels. LPA (Layered Process Audit) log records compliance. Full revision history with audit-ready exports. Built for quality leaders, training coordinators, and manufacturing supervisors in regulated industries.
Taktly grades CAPA / RCA work against the exact patterns FDA cites in Warning Letters: operator-error root causes, training-only CAPAs, 'continue to monitor' effectiveness, undefined targets, missing prior-occurrence search. The 5-reviewer panel (MBB / FDA reviewer / CFO / plant manager / sponsor) reads every confirmed root cause through its own skepticism lens. Devil's Advocate review on every confirmed cause.
Taktly is graded against 21 CFR 211, 21 CFR 820, ICH Q7 / Q9 / Q10, EU GMP Annex 1, ISO 13485, ISO 14971, ISO 9001, IATF 16949, AS9100, FSMA, HACCP, USDA FSIS, and GFSI scheme requirements (BRCGS / SQF / FSSC 22000). The FDA Warning Letter pattern library is hand-curated from real public actions and grows weekly.
Drop a charter, CAPA, RCA, or full DMAIC into the audit. 30 seconds. Free, no signup, your data stays in your tenant.