Table of Contents
Process Validation end-user requirements #
The process validation module will enable the company to comply with regulatory requirements and ensure that all critical manufacturing processes are validated and maintained in a validated state.
Level 1 – Process Validation end-user requirements #
| Ref. ID | End-User Requirement (Theme / Epic level) |
|---|---|
| X.1 | As a quality manager, I want to implement a process validation module as part of the quality management system so that the company can comply with regulatory requirements and ensure that all critical manufacturing processes are validated and maintained in a validated state, leading to improved quality outcomes and reduced risk. |
Level 1 – Process Validation end-user requirements Acceptance Criteria. #
| Ref ID. | Acceptance Criteria |
|---|---|
| X.1.1 | The process validation module should provide a standardized process for process validation, including documentation and approval workflows. |
| X.1.2 | The module should allow for the tracking and monitoring of all process validation activities, including status and completion dates, with notifications and reminders to ensure timely completion. |
| X.1.3 | The module should integrate seamlessly with the existing quality management system, including workflows and notifications. |
| X.1.4 | |
| X.1.5 | |
| X.1.6 | |
| X.1.7 | |
| X.1.8 | |
| X.1.9 |
Level 2 – Process Validation end-user functional requirements #
| Ref ID. | End-user functional requirements (User Story ) | Criticality |
|---|---|---|
| X.2.1 | As a quality assurance manager, I want to be able to create process validation plans, so that I can ensure that all critical processes are validated and meet regulatory requirements. | High / Low |
| X.2.2 | As a process engineer, I want to be able to document and execute process validation protocols, so that I can ensure that the process meets design specifications and is consistently producing quality product. | High / Low |
| X.2.3 | As a quality control analyst, I want to be able to review and approve process validation reports, so that I can ensure that the process has been properly validated and is in compliance with regulatory requirements. | 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 3 – Process Validation non-functional system requirements #
Visit our non-functional system requirements page for an overview of non-functional system requirements.
