Karthik Kumar Email & Phone Number

SaaS Governance / GxP Cloud Compliance, Data Integrity, and Data ManagementOngoing Change Management Support for Regulated Applications and Quality AssuranceVendor Qualification (Hosted Providers, CRO, CMO, GXP Software Developers)Audit Readiness and Support, Computer Software AssuranceIncident and CAPA ManagementRisk-based Systems Implementations (Computer Systems Validation)Quality Management Systems / IT Compliance Processes and Procedures.Design and Development of Regulatory Compliance Software Suite for Life Sciences:Electronic Change ManagementSmart Document ManagementGxP AssessmentsExperienced in validating key industry systems - NuGenesis SDMS, Empower CDS, TrackWise 8.5 (CAPA, Change Control, Complaint Investigation), Learning Managing Systems (LMS), Laboratory Information Management System (LIMS), Electronic Notebook (ELN), Veeva Quality Management System (Audits, CAPAs and Change Control), Veeva eTMF, Veeva QualityDocs, Veeva RIM, Business Intelligence Reports, Cognos Framework and EDMS,LABX,PERKIN ELMER,CHARLES RIVER,BECKMAN COULTER.Extensive experience and knowledge of Validation Life cycle, Software Development Life Cycle (SDLC), QA Methodology, Testing Life Cycle, Security Compliance, Data Migration and Data IntegrityHighly proficient in drafting GxP Documentation - IQ, OQ and PQ protocols, Validation Plan, Risk Assessments, Data Integrity Assessments, Requirements, Configuration Specs, Validation Summary Reports etc.Well versed with FDA regulations including 21 CFR Part 11, 210, 211, 820 and ISO regulations and GAMP5Equally comfortable working in an Agile or Waterfall SDLC environment.