IT Compliance Consultant & Computer Systems Validation Consultant.
Qualification and Validation of ERP, EDMS, Data Center, IT Infrastructures, MES, Dispensing System, SAS, DCS, SCADA, PLC, Machinery, HVAC, LIMS, CDS, Laboratory instruments, Spreadsheets, Databases, Warehouses Management System, BarCode/Rfid System.
Consulting and training for Computer System Validation, FDA 21 CFR part 11, Compliance to GxP regulations, Quality Management Systems.
Auditing for supplier selection and qualification.
Definition, preparation and review of IT Standard Operating Procedures.
Compliance Assessments: Validation Master Plan, GxP Risk Analysis, Periodic Review, Remediation Plan.
Contact Details
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