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  • Testing & Validation

    When a business implements a new computer-based system or needs to validate an existing system, they will need to provide evidence to show that the system does exactly what it is designed to do, that it is consistent, accurate, reliable, traceable and secure.

    To achieve this, there are a number of requirements that need to be completed before a system is considered fully validated.

    SoftNLabs can help you achieve a successful validation project.

     

    SoftNLabs can be of assistance
    by constructing or reviewing the following:

    Validation plan

    Validation Plan

    The validation plan defines the validation activities and deliverables required to demonstrate that the system to be validated performs as intended in a reliable, secure and compliant manner.

    A validation plan should include:

    • the documentation that is to be produced during the validation process
    • the timeline for the validation process
    • the participants of the validation process such as the resources, personnel, and departments involved. It is important to define the roles and responsibilities: who are RESPONSIBLE, ACCOUNTABLE, CONSULTED & INFORMED (RACI)
    • the criteria required to show that the system meets the defined requirements
    • the compliance requirements of the system and how the system is to meet them
    Test cases

    Test cases

    The successful completion of testing verifies the system performs as intended.

    • Installation Qualification (IQ) Scripts and Results: The IQ testing and results verify that the system has been correctly installed and configured.
    • Operational Qualification (OQ) Scripts and Results: The OQ testing, and results verify that the system does what it is intended to do in the user environment.
    • Performance Qualification (PQ) Scripts and Results: The PQ testing and results verify that the system is fit for intended use according to the procedures and processes set out in the URS.
    Reports

    Reports

    • Requirements Traceability Matrix (RTM): The RTM links the requirements to the test cases to demonstrate that all the requirements have been covered in the testing.
    • Validation Summary Report: The Validation Summary Report is a review of all activities and documents against the Validation Plan.
    • System Release Report: The System Release Report documents that validation activities are complete, and the system is available for intended use.
    Risk Assessment

    Risk Assessment

    A risk assessment is to document any potential compliance and business risks associated with the system.

    The analysis rates the risk of each requirement for the system and helps to implement strategies to mitigate possible risks.

    One example methodology for system validation is following the V Diagram, as shown in the diagram below:

    There are a number of pitfalls that you need to be aware of when conducting a computer system validation project.

    Below are some examples of common pitfalls that should be avoided:

    • Poor planning:

    Poor planning can lead to a poorly run validation project or even an unsuccessful outcome. It is important to create a good validation plan (VP).

    • Poorly defined requirements:

    Inadequately or poorly defined user requirements specification (URS) / functional specifications (FS) can result in the system not being able to be verified it is working as intended. A clear and precise set of requirements is essential to allow for the accurate testing of the system and to show it does what it is intended to do.

    • Lack of resources:

    Often, day to day business needs of members of the project team can take precedence over the project. This can have an impact on the time dedicated to the project, leading to delays or the project being abandoned. The project team should ideally have dedicated and experienced members.

    • Time wasting:

    To avoid wasting time and cost on low value testing, it is important to conduct a risk assessment to determine the level and aspects of the system that require testing. Focus should be on what is achievable and practical to satisfy regulatory and quality compliance. It is important not to get bogged down in the “Nice to haves”.

    • Inadequate / Excess documentation:

    It is essential to know what documentation is required for the validation of the system. Too little will not satisfy quality and compliance. Too much can lead to an overrun and costly project.

    We have the pleasure to work with

    the following industries:

    pharmaceutical

    food & beverage

    chemical & petrochemical

    laboratory

    other activities

    Any project?

    Our team is available for you.