System Overview

Welcome to the Pure Global File Management System. This guide provides a quick introduction to the core features.

Introduction

The Pure Global File Management System is a project management platform for medical device regulatory compliance. Built around the "Task Library → Checklist → Project" workflow, it helps teams efficiently manage tasks and files required for regulatory submissions across countries.

Core Concepts

Task Library

The Task Library is a collection of reusable task templates. Each template represents a regulatory compliance task, containing a name, description, and reference files, categorized by country/region.

Task templates can be reused across multiple projects without duplication.

Checklist

A Checklist is a curated set of task templates. Based on the target country, device type, and risk level, related task templates are organized into a standardized work package.

When creating a project, selecting a Checklist automatically generates all required tasks.

Project

A Project represents a specific regulatory submission, belonging to a client company. By selecting a Checklist when creating a project, the system automatically generates all required task instances, allowing team members to begin working immediately.

Projects bring together tasks, files, and team collaboration in one place — tracking progress from initiation through to delivery.

Typical Workflow

1. Preparation: Create task templates in the Task Library, then combine them into Checklists
2. Project Setup: Create a Project for a client company and select the appropriate Checklist
3. Execution: Team members complete tasks, upload files, and submit for review
4. Delivery: Once all tasks are complete, deliverables are archived in the Deliverable folder