When teams set out to determine the requirement specifications for a computerised system, confusion often arises. However there are some simple steps you can take that will help you build up a clear picture of the requirements along with getting buy-in from everyone involved.
It’s all about the process
In order to determine the requirements accurately, you will first need a solid understanding of what the eventual computerised system needs to do. Whether you follow SIPOC (suppliers, inputs, process, outputs, customers) or another process mapping method, make sure you spend enough time exploring and questioning your beliefs about the target process. You can do this by conducting small group interviews and hosting discovery workshops, as well as reviewing relevant documentation.
You could then try developing a prototype. This can highlight things you might have inadvertently left out when you initially set out to describe what the system would need to do.
For example, when creating a new process setup in Jira, use a development system to devise a rough implementation of the process. You can then share that with the users and ask for feedback. This will help to identify fundamental errors like missing steps and duplication as well as revealing misconceptions and unexpected ideas.
If your platform doesn’t allow for quick prototyping, use storyboards instead.
A good description of the eventual process will form the basis of your user requirements and operating instructions. It will also help to make clear how regulatory requirements will impact the process, for example the need for electronic records to be created and training provided.
Taking regulatory requirements into account
It’s vital to consider the relevant regulations when working out the requirements of your implementation. Your best bet will be to add regulatory requirements to your list and manage them exactly as you would user requirements.
For the implementations we do, the two major sources of regulatory requirements are:
- The FDA Code of Federal Regulations, Title 21, part 11 (CFR 21 part 11 )
- Europe’s Annex 11
It’s important to follow legal requirements to the letter, so you you may want to consult an expert ensure that you fully understand how the regulations governing your industry will affect your implementation.
Requirement specifications in Jira
Jira is the perfect place to specify your requirements. Start by defining a dedicated custom issue type called ‘Requirement’. Using this to describe the requirements of the process will enable you to trace their connections with functional specifications and make sure none of the requirements are ignored in the development or testing process.
