Table of Contents
Qualification and Validation end-user requirements #
The module will enable the company to comply with regulatory requirements and ensure that all critical processes are validated and qualified for their intended use.
Level 1 – Qualification and Validation end-user requirements #
| Ref. ID | End-User Requirement (Theme / Epic level) |
|---|---|
| X.1 | As a quality manager, I want to implement a qualification and validation module as part of the quality management system so that the company can comply with regulatory requirements and ensure that all critical processes and equipment are validated and qualified for their intended use, leading to improved quality outcomes and reduced risk. |
Level 1 – Qualification and Validation end-user requirements Acceptance Criteria. #
| Ref ID. | Acceptance Criteria |
|---|---|
| X.1.1 | The qualification and validation module should provide a standardized process for the qualification and validation of equipment, processes, and systems, including documentation and approval workflows. |
| X.1.2 | The module should allow for the tracking and monitoring of all qualification and 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 – Qualification and 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 track all the validation and qualification activities in the system, so that I can ensure that all necessary steps have been completed. | High / Low |
| X.2.2 | As a validation engineer, I want to be able to create validation and qualification protocols in the system, so that I can document and track the progress of validation and qualification activities. | High / Low |
| X.2.3 | As a laboratory manager, I want to be able to define acceptance criteria for each validation or qualification activity, so that I can ensure that the activity is completed satisfactorily. | 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 – Qualification and Validation non-functional system requirements #
Visit our non-functional system requirements page for an overview of non-functional system requirements.
