moon-eqms System Requirements Document

Introduction

The purpose of this document is to outline the system requirements for the moon-eqms project, an electronic Quality Management System (eQMS) designed specifically for a pharmaceutical company registered with the US FDA. This document will detail the necessary features and functionalities to ensure compliance with industry standards and enhance operational efficiency.

System Overview

The moon-eqms platform aims to provide a comprehensive solution for managing quality processes within a pharmaceutical company. It will include modules for document management, ticketing, CAPA (Corrective and Preventive Actions) management, approval processes, and workflow management. The system will ensure compliance with US FDA regulations and streamline quality management processes.

Functional Requirements

• As a Quality Manager, I should be able to manage documents to ensure compliance with regulatory standards.
• As a User, I should be able to create and manage tickets for quality issues.
• As a Quality Manager, I should be able to manage CAPA processes to address and prevent quality issues.
• As an Approver, I should be able to approve documents and processes to ensure compliance.
• As a Workflow Manager, I should be able to design and manage workflows to streamline quality processes.
• As a User, I should be able to access a dashboard that provides an overview of quality metrics and KPIs.
• As an Admin, I should be able to configure user roles and permissions to ensure secure access control.
• As a User, I should be able to receive notifications for tasks and approvals to stay informed of my responsibilities.

User Personas

• Quality Manager: Oversees quality processes and ensures compliance with regulatory standards.
• User: Engages with the system to report issues and participate in quality processes.
• Approver: Responsible for approving documents and processes.
• Workflow Manager: Designs and manages workflows to optimize quality processes.
• Admin: Configures system settings, user roles, and permissions.

Core User Flows

• Quality Manager uploads a document -> Document undergoes approval process -> Approved document is stored in the system.
• User reports a quality issue -> Ticket is created -> CAPA process is initiated -> Issue is resolved and documented.
• Workflow Manager designs a new workflow -> Workflow is tested and approved -> Workflow is implemented in the system.
• Approver receives a document for approval -> Reviews and approves the document -> Document status is updated.

Visuals Colors and Theme

• primary: #2A9D8F (teal)
• primary_light: #A8DADC (light teal)
• secondary: #E63946 (crimson)
• accent: #F4A261 (orange)
• highlight: #E9C46A (gold)
• bg: #F1FAEE (light cream)
• surface: rgba(233, 245, 248, 0.8)
• text: #1D3557 (dark blue)
• text_muted: #457B9D (muted blue)
• border: rgba(38, 70, 83, 0.2)

Signature Design Concept

The moon-eqms homepage will feature an interactive 3D molecular structure that users can manipulate. Using @react-three/fiber and @react-three/drei, the structure will rotate and expand as users hover over different sections, each representing a module of the eQMS. Clicking on a section will zoom into detailed views of the module, providing an engaging and educational experience. This dynamic interaction will symbolize the interconnectedness of quality processes in the pharmaceutical industry.

Interaction Model & Motion Direction

The landing page will utilize a "parallax" interaction model, creating a sense of depth as users scroll through the content. Layers of molecular structures and quality process diagrams will move at different speeds, enhancing the storytelling aspect of the platform. Internal pages will adopt a "static" model to prioritize clarity and ease of use for data-heavy tasks.

Non-Functional Requirements

• The system must ensure data security and integrity to comply with regulatory standards.
• The platform should support high availability and scalability to accommodate growing user demands.
• The user interface must be intuitive and accessible to users with varying levels of technical expertise.

Tech Stack

• Frontend: React for Web
• Backend: Python, FastAPI
• Database: MySQL or MariaDB, using Alembic for migrations
• AI Models: Not applicable
• AI Tools: Not applicable
• Local Orchestration: Docker, docker-compose
• Server-side Orchestration: Kubernetes

Assumptions and Constraints

• The system will be deployed in a cloud environment to ensure scalability and reliability.
• Compliance with US FDA regulations is mandatory for all system functionalities.
• User training will be provided to ensure effective adoption of the system.

Glossary

• eQMS: Electronic Quality Management System
• CAPA: Corrective and Preventive Actions
• FDA: Food and Drug Administration
• KPI: Key Performance Indicator

This document serves as a comprehensive guide for the development and implementation of the moon-eqms platform, ensuring it meets the needs of a pharmaceutical company registered with the US FDA.