• Validation – applies to a process; ensures proper operation with safeguards against improper processing; verifies software and qualified hardware are suitable to do a process that may include many tasks

    Validation is…

    • The establishment of documented evidence that a system or process does what it is intended to do
    • It encompasses verification. Validation asks “Are we building the right system?” and verification asks “Is the system being built right?”
    • Qualify equipments vs. Validate processes

    Users of the computer system are responsible for validation

    • Is performed on the same environment as the production (hardware, software, OS, data)
    • Is performed before production use or before changes are made in production system
    • It addresses System requirements and installation, Training, Risk assessment, operational verification, controlled corrective actions…

    Standard Validation

    Validation is one of the most significant pre-requisites for a pharmacovigilance system. Validation would ensure that the functionality is working as per the standard

    Standard validation would include:

    • Validation documents would be available as per the Sarjen system’s templates
    • Validations documents set out in the contract agreement will be delivered

    Customized Validation

    Customized validation would include:

    • Customized validation as per client’s requirements
    • Validations documents as per client’s template
    • Validation documents as set out mutually in the agreement