Computer System Validation - CSV Lead Auditor

  • CSV Validation and re-validation

  • Part 11 assessment and remediation

  • CSV Audit and Inspection

  • Periodic Review and System

  • Decommissioning

  • CSV &GxP Trainings need-based

  • CSV Capability Maturity Assessment

  • COTS Package assessment

  • He has been involved in delivering high-valueCSV consulting projects for Global 100Pharmaceutical companies for the last 15 years. Hasbeen instrumental in setting up Regulatory IT CoEdivision for IT majors in India thus creating a GlobalOffshore-Onsite Delivery Model. His core strengthsare in Validation, Re-validation, Audit & GapAssessment, Portfolio Assessment, CapabilityMaturity Assessment, Periodic Review and SystemRetirement and Data Integrity Remediationengagements.

  • Drug Discovery and Clinical Systems –Has been involved in validating and re-validating andconducting periodic reviews of major GxP criticalDrug Discovery and Clinical Trial ManagementSystem and Clinical Data Management System andLIMS (Empower). Understands the businessprocesses involved in undertaking a clinical trialstudy, collection of data and the bio statistical reviewsof the data. Has also worked in validating a CTMSsystem developed in-house by an Indian IT major andbeen used by a Danish Pharmaceutical company fortheir

  • Manufacturing IT Systems –Has been involved in upgrade and re-validation ofManufacturing IT systems like SCADA, BAS, BMS,EMS systems in Pharmaceutical companies, wherethey went for equipment upgrade and also PLC/HMIand Operating System upgrade. Worked as part ofteam in qualifying major systems like Purified WaterSystems, Building Management System, Clean Roomutilities on SIEMENS, Rockwell technologies. Hasbeen involved in Part 11 and Data Integrityremediation projects as part of post-audit andinspection process.Phase II and III clinical trials.

  • Enterprise Systems -Has been involved in validating, upgrade andPeriodic reviews, Data Migration, Cloud-basedvalidation of eDMS (Electronic Data ManagementSystem), LMS (Learning Management System),SAP HANA, Documentum, Livelink, Opentext, MSSharepoint Portal, Slide Scanner System, TobaccoManufacturing Automation System, legacy-basedSpreadsheet system used in Clinical Trial datacollection.

  • Pharmacovigilance System –Has been involved in installation and validation,upgrade, and re-validation of ARISg for the platformand cloud-based model.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in