Pre-Review Intelligence — Catch weak CI work before review, not after
The layer that strengthens work before review
Continuous improvement projects don’t fail in planning. They fail in execution.
Most tools collect the work. Taktly strengthens it before review — catching weak root causes, vague CAPAs, unsupported savings, and the language reviewers reject, then rewriting them with your numbers. Built for Quality, OpEx, and CI teams in pharma, medical device, and regulated manufacturing.
Drop a charter, A3, CAPA, root cause, business case, standard work, or full DMAIC. Your first senior review in 30 seconds. Free. No signup.
or paste
Free · No signup · 30 seconds · Your data stays in your tenant
Sample report preview
CAPA · fill-finish
Overall score
0/100
2 hard refusals · 4 weak · 1 missing
Industry · fill_finish
Scrutiny · critical
FDA 483 likelihood · 72%
Hard refusal ·Operator error attributed as terminal root cause
Hard refusal ·Effectiveness check: ‘continue to monitor going forward’
Weak ·Savings stated without sensitivity band ($1.2M point estimate)
MBB
revise
FDA
reject
CFO
skeptical
Plant
revise
Sponsor
revise
This is a sample. Run yours →
Works on Full DMAIC · Charters · A3s · CAPAs · Root cause · Business cases · Standard work
$0 free · $149/mo Practitioner · founder pricing on teams · see pricing
CI / CAPA / DMAIC teams ship documents that look complete but get flagged at review for the same handful of failure modes. The work was already there — the writing just didn’t survive a real reviewer.
Operator-error attributed as root cause
Training-only CAPAs in regulated environments
“Continue to monitor” effectiveness
Fabricated savings without a sensitivity band
Undefined targets (“industry standard”)
Missing prior-occurrence search
What other tools do
Collect the work.
Project management tools store your documents. Templates give you a fill-in-the-blank. Generic AI writes around what you typed. None of them grade what you wrote against the patterns a real reviewer rejects.
What Taktly does
Strengthen the work.
Taktly grades your CAPA / RCA / DMAIC against the exact language FDA writes in Warning Letters, the MBB math an inspector expects, and the system-level rewrites that pass review. In 30 seconds. Free.
How it works
From your document to a defensible project in 60 seconds.
1
Drop your doc
Paste or drop a charter, A3, CAPA, RCA, business case, or full DMAIC.
2
Senior review in 30s
Score, flags, rewrites, FDA pattern matches, 5-reviewer panel verdict.
3
“Fix this for me”
One click: corrected document opens in a free project, all artifacts populated.
4
Taktly Watch stays on
After Control closes, Watch reads the metric and flags drift — for as long as you need.
Three of the most common ways CI work fails review. The left column is what teams actually write. The right column is what Taktly rewrites it to — using the same project's real context, in practitioner voice.
Operator-error root cause
Hard refusal
Sterile fill-finish, pharma
Before
Root cause: Operator failed to follow CIP cleaning SOP at the changeover, leading to contamination of Lot R-2401.
After Taktly
The CIP cycle-time deviation that produced contamination of Lot R-2401 was undetectable in real-time: the recipe permitted manual override of minimum cycle time with no alarm, no QA notification, and no automated batch-record flag. The deviation propagated to fill because the next inspection point was post-aseptic, after contamination would already be present.
Training-only CAPA
Hard refusal
Medical device, 21 CFR 820
Before
Corrective action: Retrain all line operators on the updated work instruction. Effectiveness: confirm all operators have signed off on the training matrix.
After Taktly
Containment: Hold all in-process units pending re-inspection (owner: QA Mgr, due Day 3). Corrective: Replace the visual inspection step with the new alarm-on-fail pressure check at station 4 (owner: Eng Mgr, due Day 30). Preventive: Hard-code the pressure spec in the line PLC so override requires QA sign-off; add a daily torque-check log entry (owner: Eng Mgr, due Day 60). Training is paired with the system change, not substituted for it.
Fabricated savings
Weak
Food manufacturing, mid-volume
Before
Estimated annual savings: $1.2M. Improvement will significantly reduce scrap and rework.
After Taktly
Annual hard savings: $640K point estimate (band: $320K conservative – $770K optimistic). Methodology: baseline scrap rate 6.8% × annual volume 1.4M units × cost-per-defect $6.70 = $640K avoided defects/yr at the goal target of 2.0%. Sensitivity band reflects ±50% on the goal-achievement assumption. Soft savings ($110K/yr in inspector hours) tracked separately.
The audit at the top of this page produces this same voice on your actual document — in 30 seconds.
Taktly Watch
Closure is the start of sustainment, not the end.
Most CI tools end at the Control tollgate. Taktly stays. After every project closes, Watch reads the verification metric and flags drift — so the gains you booked don’t quietly evaporate six months later.
Sustainment dashboard
12 closed projects · Watch verdicts
Live
Holding
9/ 12
Drifting
2/ 12
Regressed
1/ 12
Awaiting data
0/ 12
Holding98% retentionPharma · Plant A · closed 142 days ago
Fill Line 7 — sterility-positive rate
Holding the improvement at 98% of the target gap. Trend is holding or improving (slope -0.012 per sample).
Holding93% retentionAuto manufacturing · Plant B · closed 87 days ago
Line 3 — assembly station 2 cycle time
Holding the improvement at 93% of the target gap. Trend is holding or improving (slope -0.004 per sample).
Drifting62% retentionMedical device · Plant C · closed 64 days ago
Line 2 — visual-inspection reject rate
Drift detected — retention slipped to 62% and trend is moving back toward the baseline (slope +0.019 per sample). Owner should review the standard work this week.
Regressed32% retentionFood manufacturing · Plant D · closed 213 days ago
Filler #4 — fill-weight CoV
Regression — retention is at 32%; the metric has effectively returned to baseline. Reopen the project or run a refresh CAPA.
Holding91% retentionBiotech · Plant A · closed 31 days ago
Mixing room — batch cycle variance
This is what every CI Director’s Monday morning should look like — 12 closed projects, 11 still holding their gain, 1 drifting (owner notified), 0 surprises six months later.
Three prior attempts had stalled. Taktly got the charter signed in 4 days.
Ashley Dupigny-Leigh, QC Supervisor at a regulated biopharma site, cut her team’s data-review error rate from 4.8% to 1.6%in 12 weeks — on a 21 CFR Part 11-visible process. Three audit findings the previous quarter: eliminated.
0
Audit findings
vs. 3 prior quarter
−67%
Data-review errors
4.8% → 1.6%
−81%
Charter cycle
3 wks → 4 days
180
Analyst hours / yr
recovered
“It didn’t just help me organize my thoughts — it helped me quantify them, clarify the purpose of the project, and turn ideas into something actionable.”
Stop fixing work at review. Strengthen it before review.
Ricardo Williams, SNAP Employment & Training Manager, used Taktly to surface gaps in logic, action planning, and documentation beforethe work hit the review gate — not after. The same pain every CI program lives with, in a totally different setting from manufacturing.
The story
A SNAP Employment & Training department needed a better way to improve the quality of internal work before it moved forward for review. Plans, corrective actions, and improvement work often looked complete at first but still required late clarification, rework, and stronger logic before they were ready. By using Taktly earlier in the workflow, the department was able to catch weak work sooner, strengthen documentation and action planning, and move forward with greater confidence.
✓
Weak work caught earlier
✓
Less late-stage rework
✓
More structured action planning
✓
Stronger documentation pre-review
✓
Manager confidence in outputs
✓
More disciplined workflow
“Taktly helped us strengthen the work before review instead of fixing it after the fact. It brought more rigor into the workflow and made the outputs stronger before they reached review.”
“That changed the quality of what the team was producing.” — Ricardo
How the score works
The math, the standards, and the review panel inside every audit.
Taktly isn’t a wrapper around a generic AI. It’s a disciplined engine graded against the regulations a real reviewer cites — with the math an MBB does by hand built in.
Capability math
Cp, Cpk, σ-level, DPMO on every dataset — AIAG SPC conventions, 1.5σ shift.
FMEA / RPN
S × O × D scored on every Improve action. RPN ≥ 120 forces a mitigation plan.
Devil’s Advocate
Adversarial AI review on every confirmed root cause. Returns specific objections with severity.
Taktly Watch
Post-closure drift detection so the gains you booked don’t quietly evaporate.
Taktly review panel
5 reviewers · 5 angles · 5 verdicts
Other tools have one voice. Taktly seats a panel — each reviewer reads the same document through their own skepticism.
Will this hold up if my Quality or Compliance lead reviews it?+
Yes. Taktly never edits your document. Every suggestion is advisory. Every change requires your explicit acceptance, and every decision lands in an audit trail with your name and a timestamp. It’s built to make your work moredefensible — not bypass your governance. Read the human-in-the-loop policy before your next QA meeting.
Does Taktly ever change my document on its own? How does human-in-the-loop work?+
No. Taktly never edits your document. Every suggestion arrives as a draft with a visible provenance chip and requires your explicit accept, modify, or reject. Every decision lands in a project audit trail with your name and a timestamp. Nothing ships to a tollgate-bound artifact silently. You can also set the engine to Coach mode (only speaks when asked), Audit mode (drafts; you accept each), or Autopilot (drafts + auto-saves as unverified for batch review). See the full policy.
What happens to my document after the audit? Do you keep a copy?+
Your data stays local.For the free audit, your document is processed server-side and the source text is not persisted past the response. Nothing is shared with other customers. Nothing is used to train models. For signed-in projects, your work is stored only in your own tenant with row-level security — isolated from every other Taktly customer. Read the Trust & Security page.
Where does our data live? Is anything shared?+
Your data stays in your tenant. The free audit runs server-side without persisting your document beyond the report. Signed-in projects are stored in your isolated workspace with row-level security. We never use customer documents to improve the engine. Full details on the Trust & Security page.
What if my reviewer is skeptical of automated tools?+
Then they’ll trust Taktly faster than any tool they’ve seen. Nothing ships without your explicit acceptance. Every change carries a name + timestamp. Every project has a chronological audit trail any inspector or procurement lead can read. The reviewer isn’t asked to trust a tool — they’re asked to read the trail of decisions a human made.
We already pay for Minitab and Veeva (or SAP / TrackWise). What does Taktly do for us they don't?+
Minitab still wins for advanced DOE. Veeva / SAP / TrackWise still own validated workflow and e-signatures. Taktly sits earlier in the process— it catches the weak root causes, vague CAPAs, and unsupported savings before they hit those systems, so your QMS stops being a graveyard for rework. See the side-by-side.
My team has 8 active DMAICs in SharePoint right now. Do I have to redo them?+
No. Upload them. Taktly reviews the work as-is, flags what’s weak, fills what’s missing, and picks up from wherever the project actually is today. You don’t restart. You strengthen.
If I bring this to my team Monday, what changes by Friday?+
You’ll have at least one CAPA, charter, or RCA rewritten to MBB grade — and a recorded review trail showing which suggestions were accepted, modified, or rejected. Most teams catch a reject-grade weakness on the first document they paste in. Value shows up before procurement does.
What kind of weak work does Taktly actually catch?+
The patterns that get caught at review everytime: operator-error root causes, training-only CAPAs, “continue to monitor” effectiveness, fabricated savings, vague targets, missing prior-occurrence search, and logic that won’t survive a senior reviewer. Most tools collect the work. Taktly strengthens it before it gets sent back.
What does the audit actually give me — and what happens next?+
A scored senior review of your work, flagged weaknesses tied to real regulatory patterns, a 5-reviewer panel verdict (MBB / FDA reviewer / CFO / plant manager / sponsor), and a rewrite for each weak section in practitioner voice. One click opens a free project loaded with your corrected work. You don’t just find out what’s weak — you walk out with the fix.
How do I justify this internally to my Director or VP?+
Run a free audit on your most recent CAPA or DMAIC. Forward the report. The reject-grade flags, the FDA Warning Letter pattern matches, and the rewrites in your team’s own voice answer the budget question for you. Most internal pitches happen in one email.
What does the free tier actually include? Where's the wall?+
Free is real. Run the audit as often as you want anonymously. Three audits per week signed in. Watermark on PDF exports. One active project. No credit card. No 14-day countdown. Upgrade only when your team is ready for unlimited projects and clean exports.
What's the cost of waiting?+
Every CAPA your team ships before reviewing it through Taktly is a CAPA at risk of getting bounced — costing rework hours, missed closure dates, audit exposure, and reviewer fatigue. The audit is free and takes 30 seconds. The cost of trying is zero. The cost of not trying shows up at your next QA review.
