Documenting and managing clear concise and testable requirements is the cornerstone for any successful validation project. Each requirement should define clearly and precisely what the system/process/software should do and state any constraints that maybe relevant.

Requirements should be reviewed and approved by the stakeholders and the subject matter experts to ensure that they meet everyone’s needs. Putting upfront effort into documenting clear unambiguous requirements will help streamline the project, reduce project risks, and of course reduce time and costs. This benefit often becomes clear later in the project where changes have the greatest impact on costs and timelines.

In this article we are going to describe a typical life cycle of a requirement from the User Requirement Specification (URS) to the Risk Assessment (RA) and then to the Requirement Traceability Matrix (RTM). Of course projects and methods are different and some projects will see requirements mapped to Functional Specifications (FS) and/or Design Specifications (DS) etc.

Managing Requirements with Kneat Validation

User Requirement Specification (URS)

The URS is one of the first documents that needs to be generated when starting your validation project. There are a number of key elements that need to be considered when creating the requirements.

• Each requirement should be clear and concise (Do not leave any room for ambiguity).
• Segregate requirements into areas/categories and get the person with the relevant expertise for each area to gather and document the relevant requirements.
• Make sure a single requirement is just that and make each one short and easy to understand. Later in the project you will see the benefits of this as it will be easier to perform a Risk Assessment, trace and test a single Requirement.
• Requirements should be testable. As you write the requirement you should be thinking about the testing i.e. where and how will it be tested. If you cannot visualise where and how it will be tested then question if you understand the need and if you are articulating it adequately.
• Avoid duplication of requirements. It’s not unusual for different stakeholders to capture the same requirement more than once. Even individuals are known to document the same requirement twice. Be wary of this and review all requirements to protect against this.
• Have a robust process for processing, managing and communicating changes to Requirements in a timely manner.

GET SMART!

Make sure all requirements are:

• Specific
• Measurable
• Achievable
• Realistic
• Testable

Fig 1: User Requirement Specification Using Kneat Validation™

Risk Assessment (RA)

Once the URS has been approved and signed off the next logical step would be to risk assess each requirement and decide on a strategy to manage each risk.

What is Risk?

Once you have an approved version of the URS the next logical step would be to risk assess each requirement and decide on a strategy to manage each risk. There are many risk methodologies which can be used but generally the process should assess risk scenarios associated with each requirement and the potential impact on patient safety, product quality and data integrity.

If the risk is unacceptable then design a mitigating control which in itself may become another user requirement. Also document where the specific risk control will be tested.

• How likely is the scenario to happen?
• If it does happen, what are the consequences?

There are many different ways in which risk can be assessed and many different tools that can be used to help. For example some of the more common tools which facilitate risk analysis are:

• FMEA – Failure Mode Effects Analysis
• HACCP – Hazard Analysis & Critical Control Points
• HAZOP – Hazard Operability Analysis
• FTA – Fault Tree Analysis
• PHA – Preliminary Hazard Analysis

Risk assessments can be time consuming and technically challenging. It is often difficult to reach consensus from the assessment group as to what constitutes risk, its severity and its likelihood of occurrence.

It is advisable to have a trained chairman and include as many of the stakeholders and relevant subject matter experts as possible. As the risk assessment progresses it is important to communicate the outcomes to the relevant stakeholders to ensure the recommendations get implemented promptly, thereby minimizing schedule and cost impacts.

Fig 2: Risk Assessment Using Kneat Validation™

Requirement Traceability Matrix (RTM)

The RTM is an excellent tool in the overall management of requirements as it allows you to track the individual requirements throughout the project. So at a glance you can see where within a deliverable the requirement was designed and tested. In essence you can see how the requirements are mapped throughout the project.

However, with the current manual paper systems based on Microsoft Word/Excel the RTM is difficult to maintain due to the project dynamics and the lack of suitable functionality available in these systems.
Using a specifically designed computer application such as Kneat ValidationTM will address these issues and enable a more consistent, structured and repeatable approach.

Fig 3: Requirement Traceability Matrix Example Using Kneat Validation™

Managing the Requirements and the Traceability Matrix

Managing requirements and traceability matrices is an on-going concern with the majority of validation projects. The main reason for this is the lack of suitable functionality available in MS Word and MS Excel.

Such tools are perfect for document authoring but when it comes to managing technical validation projects, the ever growing need for computer systems is evident.
In the video posted, I explain how this is possible and how easy this tool makes managing requirements throughout the complete project.

Unlike other requirement management tools, this application has been developed specifically for the life sciences so all of the controls necessary for 21 CFR Part 11 and Annex 11 are ingrained in it.
If you would like to learn more about this application feel free to contact me directly or visit www.kneat.com to learn more.

If you would like to learn more about this application feel free to contact me directly or visit www.kneat.com to learn more.