Training activity information
Details
Complete a validation or verification plan
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Validation and verification
- Requirements for a validation or verification plan
- Quality management
- Does the plan validate the project
- Safety of patient data
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What are the specific goals of this validation or verification plan?
- What do you already know about system validation and verification processes and planning? What specific insights do you hope to gain from completing this plan?
- How does this activity relate to the relationship between requirements, acceptance criteria and system testing?
- What key success criteria will you consider when developing the plan?
- What steps will you take to prepare the validation or verification plan?
- What potential difficulties might arise during the validation or verification process, and how can your plan address these?
- How do you feel about planning this validation or verification activity?
- What background information about the system and its requirements do you need before creating the plan?
In action
- What specific steps are you currently taking to develop the validation or verification plan?
- How are you deciding on the validation and verification methods to include? Why are you choosing these methods?
- What decisions are you making about the scope, criteria, and responsibilities within the plan as you develop it?
- What aspects of planning validation or verification feel intuitive, and what aspects require more thought and effort?
- How is the development of your plan progressing towards the goal of creating a comprehensive validation and verification strategy related to managing a system development project and implementing new applications/upgrades?
- How effective are your current planning actions in defining clear and measurable validation and verification activities?
- What challenges are you facing in determining appropriate test cases or defining acceptance criteria?
- What can you learn about validation and verification planning as you create this document?
- How does this planning activity connect with your understanding of system development lifecycles and quality assurance?
- How are you adapting your plan based on your understanding of the system requirements and potential risks?
- Are there alternative validation or verification techniques you should be considering?
- Do you need to seek support or clarification on any aspects of validation or verification planning at this time?
- Are you ensuring that your plan aligns with best practices and the scope of this training activity?
On action
- Summarise the key components of the validation or verification plan you completed. What were the main aspects of the system development that your plan focused on? What specific validation or verification activities did you include? How did you address different levels or types of testing (if applicable)?
- What skills or knowledge did you develop or improve in relation to validation and verification planning? What did you learn about the importance of validation and verification in the system development lifecycle? Were there any unexpected considerations or challenges you encountered while developing the plan? What did you learn from these? How did your thinking during the planning process (reflect-in-action) shape the final validation or verification plan? How does creating a robust validation or verification plan contribute to the successful implementation of clinical systems?
- What areas for continued development in validation and verification planning have been identified? How can you apply the learning from this activity to future system development projects? What actions or ‘next steps’ will you take to enhance your skills in this area? What support or resources might be beneficial for further development, such as exploring different testing methodologies or regulatory requirements?
Beyond action
- Considering your current knowledge of system testing and quality assurance, how would you evaluate the validation or verification plan you created? What aspects would you approach differently now? Have you been involved in other validation or verification activities since this training activity? How did this initial planning experience inform your later approaches? Did feedback from your training officer or peers highlight any areas of validation or verification planning you need to consider more carefully? Re-examine your reflect-on-action notes for this training activity. Has your understanding of the difference between validation and verification broadened since then?
- Has your understanding of validation and verification principles influenced how you approach system testing or the implementation of new applications and upgrades? Has this exercise helped you understand the importance of ensuring system quality and reliability in a clinical setting? How has this training activity contributed to your understanding of the need to critically evaluate and manage a system development project within a formal project management methodology? Has it influenced how you critically evaluate the flow of information between systems?
- What skills in planning, attention to detail, and quality assurance did you develop through this training activity that will be valuable in ensuring the integrity and reliability of clinical systems? What further learning or resources will you seek to enhance your expertise in validation and verification planning? How will your ability to create robust validation and verification plans contribute to the successful deployment and maintenance of healthcare systems in your future career?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 |
Outcome
Critically evaluate and manage a system development project within the context of a formal project management methodology. |
| # 6 |
Outcome
Implement new applications and upgrades to an existing application using controlled methodology. |