TTC (Through The Cords) — Complaint + CAPA Workflow Designed to Support ISO 13485 / FDA QSR

TTC (Through The Cords) operates in a medical-device-adjacent space where complaint handling and corrective-action workflow have to be designed against regulatory standards like ISO 13485 and FDA Quality System Regulation (21 CFR Part 820). The workflow has to be reliable enough that an auditor can trace any complaint from intake through investigation to root cause and corrective action — without manual reconstruction.

Scope-limiting note up front: the workflow is designed to support ISO 13485 and FDA QSR — it is not certified to those standards. Certification is the client's own audit responsibility; the system gives them the data and the traceability the audit requires.

The Challenges TTC Faced

• Complaint intake scattered across channels. Complaints came in via email, phone, distributor relationships, and field reports. There was no single intake queue, which meant nothing was reliably tracked from the moment it arrived.
• Investigation steps with no audit trail. Investigation work happened in shared documents and email threads. By the time CAPA was opened, reconstructing the investigation timeline for the audit was forensic work.
• CAPA tracking that fell behind. Corrective and preventive actions were tracked in spreadsheets. Status updates depended on the CAPA owner remembering to update the sheet, and overdue actions were invisible until someone looked.
• Audit preparation as a project of its own. Pulling together the evidence for an external audit took weeks of preparation because the data lived in too many places.

How Linescripts Built the Solution

One intake queue for complaints, regardless of channel

Every complaint lands in one queue with a structured record — source, severity, affected product, affected lot, reporting customer, intake timestamp, and intake operator. Email, phone, distributor reports, and field reports all route to the same record type so the audit trail starts at intake.

Triage and investigation as structured workflow

Each complaint moves through a defined lifecycle (received → triaged → under investigation → root cause identified → CAPA opened → CAPA closed → closed) with mandatory fields at each transition. The transitions and the field-level changes are captured as audit history automatically — investigation timeline reconstruction stops being forensic work.

CAPA records linked to source complaints

CAPAs are first-class records with owners, due dates, evidence attachments, and effectiveness-review checkpoints. Every CAPA links back to the complaint or complaints that triggered it. Overdue CAPAs are visible on a dashboard rather than discovered during audit prep.

Role-scoped access

Quality, manufacturing, regulatory, and management each see the views and actions appropriate to their role. Quality sees the full complaint inventory and CAPA pipeline. Manufacturing sees CAPAs they own. Regulatory sees the audit-trail view across everything. Management sees aggregate trend and overdue exposure.

Audit evidence prep as a query, not a project

Because intake, investigation, CAPA, and effectiveness review all live in one connected data model, audit evidence is a structured query rather than a re-collection project. Trending, recurrence analysis, and overdue exposure are reports that already exist.

What Changed for TTC

• Complaints have one front door. Whatever channel a complaint arrives through, it lands in the same intake queue with the same data shape.
• Investigation has an audit trail by construction. Field-level history is captured automatically — the timeline is the data, not a reconstruction.
• CAPAs are visible before they become overdue. Owners, due dates, and effectiveness review all live in one tracked workflow.
• Audit preparation is a query. External-audit evidence is pulled from the live system rather than reconstructed from email threads and shared documents.

Closing

The system doesn't certify TTC to ISO 13485 or FDA QSR — that's an audit relationship between TTC and their certifying body. What the system does is give TTC the data shape and the traceability the audit requires, on a workflow that the quality team can actually run day to day. The two have to coexist: a system that's auditable but unusable doesn't get used, and one that's usable but not auditable fails the audit.