kaliyana sundaram

Lab application Implementation/Enhancement/Validation/Support LIMS – SampleManager LIMS LES & ELN, LabWare LIMS, Interface System – LabSolution, MODA EM & FDC ERP System – SAP PP-QM, MM, Navision ERP QMS – MasterControl, TrackWise QMS, ITIL system – ServiceNow, JIRA, ProcessX Process – GAMP-based V-model CSV (URS, CS, FS, IQ, OQ & PQ, Traceability matrix), CAPA, Deviation, SOP, etc.

• SampleManager LIMS, ELN, LES-IM, and Clinical Safety System and Other ERPs System • Quality Management Systems (QMS) • SDLC (Waterfall; V-model; Agile; Risk-Based Rapid Development) • cGxP (GLP/GCP/GMP), Good Documentation Practice (GDP) • GAMP Guidelines applicable to CSV • 21 CFR Part 11 Electronic Records; Electronic Signatures • EU Annex 11 Computerized Systems • ISO/IEC/IEEE Software Testing Standards • Medical Devices (ISO 13485) • IEC 62304 Medical Device Software Life Cycle

Lab Automation and extensive experience in Empower CDS 2 & 3, NuGenesis SDMS v7.1, LabWare LIMS v6, and other lab applications such as Chromeleon, Lonza MODA, etc. Computer system validation specilist

An accomplishment-driven professional offering over 7 years of work experience and gained domain expertise in Life Sciences Industry (Pharmacovigilance, Manufacturing, & R&D) -Worked towards the adherence to FDA and EU regulations; currently working as an IT Quality Consultant for one of the top US Clients • Superior knowledge of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation -