Quality Management System (QMS)

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. IDEnd-User requirement (Theme level)
X.1AS 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 requirements.

Level 1 QMS end-user acceptance criteria #

Ref ID.Acceptance Criteria
X.1.1A comprehensive suite of quality management modules.
X.1.2A user-friendly interface that enables easy retrieval and management of quality-related information and documents.
X.1.3Standardized processes for quality management activities, including documentation and approval workflows.
X.1.4Real-time tracking and monitoring of quality-related activities, with notifications and reminders to ensure timely completion.
X.1.5Automated data collection and analysis capabilities to support decision-making and continuous improvement.
X.1.6Compliance with regulatory requirements, including FDA 21 CFR Part 11 and GAMP 5 guidelines.
Level 1 – QMS end-user requirements acceptance criteria.

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