Amit Dekate's Linkedin Analytics

Experience life science professional of around 17 years in industry, handled domain of Gxp validation & data integrity consultant. currently works in domains of Computer Systems Validation, since last 8 years. have successfully implemented various enterprise level application for Pharmaceutical, medical devices and clinical organizations. the expertise for CSV includes defining business requirements for software apps, strategic decision making/ planning for GxP application followed by risk based approach based on GAMP 5. Apps implemented SAP ECC 6.0,Labware LIMS, Trackwise 8.0, LMS, DMS, HPLC- shimadzu, Labsolutions, Manufacturing Execution System, werrum PAS-X 3.1.7. providing compliance as per 21 CFR parts 11 & EU annex 11, GDPR