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    Validating pharmaceutical systems

    Is your organization ready for an inspection of your Computer System Validation program?

    In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program.

    The lack of consistency in the process creates the risk of not being capable of complying with the requirements of approved procedures.

    However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection.The list itself should be organized by Gx P (GCP, GLP or GMP) so you can sort the list accordingly during an inspection or for analysis purposes.Next, the list should include a system owner for each system so you know who is responsible for the system and who to call upon during an inspection.Val Genesis VLMS is capable of managing requirements, conducting risk assessments, generating dynamic trace matrices, electronic execution, and enforcing validation requirements through frameworks.Val Genesis VLMS eliminates non-value added manual activities that are labor intensive and time consuming while expediting the CSV process and removing inefficiencies that plague validation processes completed on paper or through an EDMS.

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