Mohammed Umer

Experience

1. Area Sales Manager

   Arizona Automation & Technologies

   Aug 2023 — Present · Hyderabad, IN

   Achieve Quality Digitalization 4.0 (GxP Software) with Arizona software comply with regulatory standards like FDA, 21 CFR Part11, GMP, EU Annex11, WHO, ISO:ü LIMS Software (Laboratory Information Management System)(AriznaLIMS)ü E-BMR and E-BPR Softwareü QMS Software (TRackQS)ü Calibration Management Software (E-CALMAN)ü Training Management / Learning Management Software (Arizona LMS)ü Documentation Management Software (EDMS)ü Excel Sheet/ Spread sheet Management Software (Arizona eXL)ü ShareDOC Software: For confidential documents sharingü Digital Validation Protocol Generation Software (E-Validation)ü Stability Chamber Sample Management Software (E-Stability)ü E-Logbook ü Sample Management Softwareü ERP SoftwareCSV Validation Services: Our deliverables as per V-Model, GAMP-5 guideline and comply with 21 CFR Part11, EU Annex11:ü PLC/HMI/IPC/ SCADA/DCS (Process Control) system validationü EMS (Environment Monitoring System) & BMS (Building Management System) Software Validationü Serialization/ Aggregation software, ReeTrak, TraceLINK,Track and Trace system and Warehouse management software and Labelling system validationü Manufacturing Execution System (MES) validationü Analytical Software Validation like SAS, WinNonlin, Chromeleon and many more.ü Laboratory Equipment Software validation like HPLC, GC, LCMS-MS, FTIR and others.ü SAP and ERP Software Validationü IT Infrastructure, Server Validation, Network Validation, Cloud system Validationü LIMS, Lab View & EMPOWER software validationü Any Customized Software Validationü Excel sheet/Spreadsheet Development and Validation (as per 21 CFR Part 11) ü Assessment: GAP / GXP / 21 CFR Part 11 ü CSV Audit, Trainingü CSV Documents review, Provide documentation support (Design in-house documents)ü Data Integrity, CQV, IT Governance and Risk Compliance, GMP, QMS Consulting