CAPA software that links each action to its cause and its evidence.

• Spreadsheets Lose the Audit Trail

  Excel CAPA logs can't prove who edited what, when, or why. The next FDA 483 starts here.

• Actions get 'closed' before they're effective

  Without a forced effectiveness check, root causes recur. The same finding reopens cycle after cycle.

• No Line of Sight from Deviation to Action

  If you can't show the auditor the chain — deviation → investigation → CAPA → retraining → verification — you don't have a CAPA system. You have a folder.

• Every CAPA is born from a real event

  Deviation, NCR, complaint, audit finding, OOS — V5 opens the CAPA with the source record pre-linked. Nothing floats free.

• Root cause that doesn't let you cheat

  5-Why and Fishbone built in. The investigator can't move the CAPA forward without naming the verified root cause.

• Action Plan with Owners, Dates, and Gates

  Tasks routed to named owners, e-signed on completion, escalated on overdue. SOP changes, training reassignments, and equipment work orders fire automatically.

• Effectiveness Check — Mandatory

  V5 won't let you close a CAPA without a defined verification window and an objective check. Closure requires e-signed evidence that the action worked.

• 21 CFR Part 11 from the first click

  Every action, every signature, every comment — captured, time-stamped, attributable, tamper-evident. The audit trail is the system.

What a CAPA actually looks like in V5 — from the deviation that triggered it to the effectiveness check that closes it.

1. Deviation Opens at the Kiosk. An operator scans an out-of-tolerance weight. V5 opens a deviation in real time, pre-linked to the lot, the operator, the SOP revision, and the equipment. The CAPA queue picks it up automatically.
2. Root Cause — Gated. The investigator opens a 5-Why or Fishbone in the same record. The CAPA cannot advance to action planning until a named, verified root cause is signed off. 'Human error' is rejected at the gate.
3. Scope Computed from Genealogy. V5 traces forward — same material lot, same equipment, same operator, same shift. The investigator sees the affected scope as data, not a guess. Quarantine fires automatically on the implicated lots.
4. Tasks routed with owners and dates. Each action gets a named owner, a due date, and a gate. SOP revisions fire training reassignment. Equipment changes fire work orders. Material changes fire supplier SCARs. No orphan tasks.
5. Operators See the Change at the Kiosk. When the SOP revises, the kiosk locks out non-current operators. When the equipment qualification changes, the line cannot start without current evidence. Drift is structurally prevented.
6. Verification — Mandatory. At the verification window, V5 surfaces the check: did the recurrence rate drop? Did the trend reverse? The closure signature is blocked without signed evidence. Pass closes the CAPA; fail reopens it and escalates.
7. Trended in the Live Dashboard. Every closed CAPA contributes to the trend by source, root cause, product, line and supplier. The next management review starts with the data, not the slide deck.

Most CAPA tools look identical in a sales demo and feel completely different on day 30. These are the criteria that separate a CAPA system that closes findings from one that just logs them.

• Source-Record Linkage

  Can the CAPA only be opened from a real event — deviation, NCR, complaint, audit finding, OOS — with the source record pre-linked? Every CAPA in V5 is born from a source record. The deviation, the OOS, or the audit finding is the parent; the CAPA cannot exist alone.

• Forced Root-Cause Analysis

  Does the system require a verified root cause before action planning, with a structured tool (5-Why, Fishbone, FTA)? 5-Why and Fishbone are built in and gated. The CAPA cannot advance to action planning without a named, verified root cause.

• Effectiveness Verification Gate

  Can the system enforce an effectiveness check window — and refuse closure without signed evidence the action worked? Closure requires an e-signed effectiveness verification within the defined window. The system refuses to close otherwise.

• Trained-on-Current-SOP Linkage

  When a CAPA changes an SOP, does the system reassign training and lock affected operators out of the kiosk until they re-train? An SOP revision driven by a CAPA reassigns training records automatically.

• Cross-Lot Impact Assessment

  Can the system compute — from the genealogy — which other lots, operators, or equipment share the root cause and may be affected? V5 traces forward from the deviation through the genealogy chain — same material, same equipment, same operator, same shift — and presents the scope.

• Trending and Management Review

  Are CAPAs trended by source, root cause, product, line, supplier — live, not quarterly? Live dashboards by source, root cause, product, line, and supplier. Management review is a meeting around the live data, not a slide deck.

• 21 CFR Part 11 audit trail

  Is every action, comment, status change, and signature captured in a tamper-evident, attributable trail? Append-only audit trail across every CAPA action. No admin override. Every change attributable to a named, trained, currently-employed person.

• Open-CAPA migration

  Will the vendor migrate your open CAPAs as part of onboarding — or hand you an Excel template and walk away? Open-CAPA migration is part of the 7-day standard onboarding. We map your existing fields and import with audit trail preserved.

How V5 compares to the two systems most regulated manufacturers run on today — spreadsheets, and a legacy QMS like TrackWise or MasterControl.

CAPA is one of the most cited subsystems in FDA inspections. Below are the clauses auditors test, what they say verbatim, and how V5's architecture answers each.

• 21 CFR 820.100(a)(1)

  V5 ingests every source — deviation, audit, complaint, return, OOS, line stop — into one record set with live trending across all of them. The trend analysis required by §820.100(a)(1) is the dashboard, not a quarterly export.

• 21 CFR 820.100(a)(3)

  Action plans in V5 carry a named owner, due date, dependency on root-cause closure, and a defined effectiveness check. Auto-routed tasks fire SOP revisions, training reassignment, and equipment work orders.

• 21 CFR 820.100(a)(4)

  V5 enforces effectiveness verification as a mandatory closure gate. The CAPA cannot be closed without signed evidence — within the defined verification window — that the action worked and did not introduce a new failure.

• 21 CFR 820.100(a)(7)

  Exports are signed, dated and reproducible.

• ICH Q10 §3.2.2

  All eight Q10 sources are first-class triggers in V5. The same CAPA record absorbs each, with no separate logs and no re-keying.

• 21 CFR 820.100 (CAPA — medical devices)
• 21 CFR 211.192 (production record review — pharma)
• 21 CFR Part 11 (electronic records & signatures)
• ISO 13485 §8.5.2 (corrective action)
• ICH Q10 (pharmaceutical quality system)

• AI CAPA Drafting
• Deviation Management
• Pharma
• Medical Devices
• Food & Beverage
• Audits & CAPA Module
• Document control
• 21 CFR Part 11
• CAPA
• Root Cause Analysis
• Effectiveness Check

What is CAPA software?

CAPA (Corrective and Preventive Action) software manages the lifecycle of findings — from the deviation, NCR, complaint or audit that triggered them, through root-cause analysis, corrective actions, training updates, and effectiveness verification before closure. Regulated industries use it to satisfy 21 CFR 820.100 (devices), 21 CFR 211 (pharma), and ISO 13485 §8.5.2.

Why not just use a spreadsheet for CAPA?

Spreadsheets can't satisfy 21 CFR Part 11 — they don't provide tamper-evident audit trails, attributable e-signatures, or controlled access. A 483 observation citing spreadsheet CAPA logs is one of the most common findings in FDA inspections of regulated manufacturers.

Does V5 enforce an effectiveness check?

Yes. V5 will not allow a CAPA to be closed without a defined effectiveness verification window and signed evidence that the corrective action worked. This is the single biggest reason auditors reopen previously 'closed' CAPAs.

How does V5 link CAPA to training?

When a CAPA action updates an SOP, V5 reassigns the affected training records automatically.

How fast can we be up and running?

We migrate open CAPAs from your existing log as part of setup.