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QMS Operations Dashboard

A lightweight Streamlit dashboard for small MedTech quality teams that still run key QMS registers in Excel.

The app ingests complaint, CAPA, FSCA/provider, PMS trend, and management-review registers, then surfaces the operating signals a Quality Manager needs for a weekly review: aging, overdue actions, complaint trends, field-action completion, and data-quality checks.

This is an educational and portfolio project. It is ISO 13485-aligned in structure and terminology, but it is not validated QMS software and does not replace a controlled eQMS.

Why This Exists

Small medical-device companies often start with spreadsheet-based registers before they can justify a full eQMS platform. The risk is that leadership loses visibility: CAPAs age silently, complaint trends are hard to see, field-action follow-up is manual, and management review becomes a scramble.

This project demonstrates how a simple operating dashboard can turn those registers into a reviewable system without pretending to be a full enterprise eQMS.

Current Features

  • Excel workbook upload for QMS register data.
  • Built-in fictional SomniAir Auto sample data.
  • Complaint trend by class and month.
  • CAPA action aging by status, owner, and function.
  • FSCA/provider completion tracking.
  • PMS signal trend view.
  • Data-quality checks for missing owners, overdue items, and field-action completion.
  • Clear disclaimer that production use would require validation and controlled deployment.

Screens Included in the App

  • Overview
  • Complaints
  • CAPA
  • FSCA / Providers
  • PMS Trend
  • Data Quality

Quick Start

python -m venv .venv
source .venv/bin/activate
pip install -r requirements.txt
streamlit run app.py

On Windows PowerShell:

py -m venv .venv
.\.venv\Scripts\Activate.ps1
pip install -r requirements.txt
streamlit run app.py

Expected Workbook Structure

The loader accepts workbooks that have title rows above the actual table headers. It searches for the table header row by required columns.

Accepted sheet names:

Data area Accepted sheet names
Complaints Complaints, Complaint Log
CAPA actions CAPA Actions, CAPA Action Plan
FSCA / provider tracker FSCA Tracker, FSCA Contact Tracker
PMS trend PMS Trend, PMS Trend Data
Management review Management Review, Management Review Inputs

Portfolio Context

The sample dataset is linked to SomniAir Auto, a fictional connected CPAP/APAP device case study. The broader portfolio includes a mini ISO 13485-aligned QMS package, risk-management file, post-market surveillance workflow, complaint/vigilance records, CAPA file, and design-change records.

This dashboard is the operational layer: it shows how the living QMS records can be reviewed and managed once the procedures exist.

Important Disclaimer

This project is not medical, regulatory, legal, or quality-system advice. It is not validated for production use. Any organization using software to support QMS processes should assess software validation, access control, data integrity, record retention, backup, change control, and cybersecurity requirements before operational deployment.

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