CAPA management

Table of Contents

CAPA Management end-user requirements #

The CAPA management module will enable the company to efficiently manage CAPAs related to the organization’s quality management system.

Ref. ID	End-User Requirement (Theme / Epic level)
X.1	As a quality manager, I want to implement a CAPA management module as part of the quality management system so that all relevant CAPAs can be easily managed, tracked, and resolved, leading to improved quality management processes.

Level 1 – CAPA Management end-user requirements.

Ref ID.	Acceptance Criteria
X.1.1	The CAPA management module should be designed to support a range of CAPA types, including corrective actions, preventive actions, and root cause analysis.
X.1.2	The module should be capable of handling a large number of CAPAs and related documents.
X.1.3	The module should have the ability to automatically assign CAPAs to responsible individuals or teams.
X.1.4
X.1.5
X.1.6
X.1.7
X.1.8
X.1.9

Level 1 – CAPA Management end-user requirements acceptance criteria.

Ref ID.	End-user functional requirements (User Story )	Criticality
X.2.1	As a quality manager, I want to be able to initiate corrective and preventive action (CAPA) requests, so that identified issues can be addressed and prevented from recurring.	High / Low
X.2.2	As an investigator, I want to be able to investigate and document the root cause(s) of the issue, so that appropriate corrective and preventive actions can be proposed.	High / Low
X.2.3	As a reviewer, I want to be able to review and approve proposed corrective and preventive actions, so that effective actions can be implemented.	High / Low
X.2.4		High / Low
X.2.5		High / Low
X.2.6		High / Low
X.2.7		High / Low
X.2.8		High / Low
X.2.9		High / Low
X.2.10		High / Low

Level 2 – CAPA Management end-user functional requirements.

Visit our non-functional system requirements page for an overview of non-functional system requirements.

Updated on March 28, 2023