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    Validating pharmaceutical systems

    Traditional computer system validation is an inefficient and time consuming paper based process that is plagued with a significant amount of inefficiencies.

    Paper-based computer system validation requires that highly skilled technical resources dedicate approximately 50% of their time on non-value added activities which include the following inefficiencies: Traditional computer system validation requires resources to dedicate a significant amount of effort to create and maintain traceability matrixes during the lifecycle.

    This creates a compliance risk over time because companies fail to maintain the traceability matrix current during the lifecycle.

    Consistency during the CSV lifecycle is another challenge of paper based validation systems.

    User Requirement Specification: URS for HPLC system is prepared to describe the critical functionalities those are required for our analysis.

    Following point should be considered during preparation of user requirement specification for a HPLC system.2.

    validating pharmaceutical systems-60validating pharmaceutical systems-28validating pharmaceutical systems-29

    In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.

    Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.

    Validation of HPLC system is most critical and important because all regulatory authorities focus on this instrument and different data integrity issues are found during FDA inspections.

    Design Qualification: Design qualification ensures that the purchased computer system is according to our user requirement specification and it is capable to run the instrument that will be connected to it.

    Inspect Computer hardware like CPU, connections, powder supply, On/Off switches etc.

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