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The transcription discusses the importance of Functional Requirement Specification (FRS) and Functional Risk Assessment (FRA) in the design phase of CSA. FRS translates user needs into functional and technical requirements, forming the foundation for designing and testing systems. The RACI matrix guides stakeholders' involvement in FRA activities. The process of creating FRS work items in Polarian is explained, emphasizing filling mandatory fields and assessing impact on patient safety, product quality, and data integrity in FRA. Risk rating and testing assurance level are key outcomes of FRA. Hello and welcome. We have got something exciting lined up for you today. Following our successful session on software validation plan, we now move forward in our CSA journey to the next key deliverable, FRS, Functional Requirement Specification and FRA, Functional Risk Assessment. This marks the beginning of the design phase of CSA. What exactly is FRS? FRS builds upon user requirement specification, which is the URS and it translates those user needs into functional and technical requirements, essentially detailing how the application should be designed or configured to meet the user requirements. That is why we mandate to have a URS document approved as an entry criteria for initiating the functional requirements documentation. But there is more beyond this. The FRS also captures the system risk requirements, but there is more. The FRS also captures system level requirements that users may not explicitly state, but which are necessary from a technical standpoint to fulfill the system's intended use. In short, the FRS forms the foundation for two important things, developing the design and configuration specification and performing scripted and or unscripted testing to confirm the system meets its intended use. Now, before we jump into creating the FRS work item, I would like to insist on a very important point, the who factors. Who should be part of this FRA activity? Follow the RACI matrix that is in your CSA procedure. It is mandate. The assessment is a collaborative effort by all the stakeholders as stated in the RACI. All right. Now, let's get started with Polarian. Just like what you did for the URS, we will begin by creating work items. We will move them into document for review and approval. All set? Now, let's start the show. In your Polarian project, go to the work items section on the left pane and click on functional requirement. Hold on, GK. I am out. Four minutes. Yes. You start from in your Polarian project. In your Polarian project, go to the work item section on the left pane and click on functional requirement. Next, click on the plus icon at the top and select functional requirement again. A black work item will open. Now, all you need to do is fill the mandatory fields precisely. The title and legacy ID if applicable. If you would want to fill other fields, it is up to you, but these two are the mandatory fields and we advise you to update the site information though it is not mandatory. Enter a brief title and provide a detailed description of the functional requirement in the description field. Now, this ends the FRS topic. Pretty simple and straightforward, is it not? With this, let us jump to the FRA. In the header section, you will find the FRA portion. This is where we perform FRA by assessing each FRS. I would like to repeat each FRS for its potential impact. So, what is the impact on? Impact on patient safety and or product quality and or data integrity. The impact may be direct or indirect or there shall be no impact also, which is none. Remember, this is done in relation to the functional implementation complexity of each requirement. Again, of each requirement. So, whether it is out of the box OOB or it is configurable or it is customizable, this aspect has to be for every single functional requirement. Select the impact and complexity based on the functional requirement that you are assessing now. So, what is the outcome of the FRA? The risk rating and the testing assurance level are the two important outcomes of the functional risk assessment. As we work on the work item now, both the fields shall be auto-populated. As we save the work item now.