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Computer System Validation

PV’s CSV services help our clients in FDA-regulated industries keep manufacturing and development running by having systems and connected equipment complying with regulatory requirements. We work with our clients to find the most effective and cost-efficient validation methods for the project. Our team of experts know what and how to prioritize based on our proven validation process and provides a comprehensive set of deliverables ready to present to an inspector based on the latest industry standards and guidelines. Our process provides our clients with peace of mind during the entire project.

At PV, we always stay current with the latest Computer System Validation industry standards and best practices. We have expertise in conducting validation projects using the latest 2nd edition of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems and FDA guidance on Computer Software Assurance (CSA – draft), General Principles of Software Validation, and Data Integrity and Compliance with CGMP. We have successfully developed and deployed complete CSV projects for systems that range in complexity from spreadsheet validation to Enterprise Resource Planning (ERP) and Laboratory Information Management Systems (LIMS).

PV serves the following areas: Pharma, Medical Device, Warehousing, Contract Research Organizations, Laboratory, Clinical Trials, Food and Cold Chain Logistics

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Kevin Marcial

CSV Services Manager - With over ten years of experience, Kevin spearheads our day-to-day operations within our Computer System Validation division. Kevin has a wide range of experience with life cycle documentation development and execution plans to ensure systems meet regulatory and intended use requirements

Schedule with Kevin Marcial