Table of Contents
Introduction #
A Quality Management System (QMS) is a formalized set of processes, procedures, and policies that define how an organization plans, implements, and evaluates its quality objectives. The primary purpose of a QMS is to ensure that an organization consistently delivers products and services that meet or exceed customer expectations and comply with relevant regulatory requirements.
Level 1 QMS end-user requirements #
| Ref. ID | End-User requirement (Theme level) |
|---|---|
| X.1 | AS a system owner, I want to implement a regulated Quality Management System (QMS) so that we cover all critical areas of quality management. |
Level 1 QMS end-user acceptance criteria #
| Ref ID. | Acceptance Criteria |
|---|---|
| X.1.1 | A comprehensive suite of quality management modules. |
| X.1.2 | A user-friendly interface that enables easy retrieval and management of quality-related information and documents. |
| X.1.3 | Standardized processes for quality management activities, including documentation and approval workflows. |
| X.1.4 | Real-time tracking and monitoring of quality-related activities, with notifications and reminders to ensure timely completion. |
| X.1.5 | Automated data collection and analysis capabilities to support decision-making and continuous improvement. |
| X.1.6 | Compliance with regulatory requirements, including FDA 21 CFR Part 11 and GAMP 5 guidelines. |
