IT GxP & IT Administration Support

✓ IT QMS, IT Administration, GxP activities, IT Infrastructure Configuration, Server Configuration & Validation, Network Configuration, Cloud System Validation.
✓ IT Administration of the GXP System like Enterprise Application (ERP, SAP, LIMS, etc.), Lab Software, Process Control Systems.
✓ Backup, Periodic Restoration of GxP System, and Archival Management.
✓ PM activity of GxP Computerized System and Server.
✓ Inventory Management of GxP Systems.
✓ Prepared & Followed SOPs: User Management, Backup and Restoration, Password Policy, Asset Management, Privileges Management, Inventory, Security Policy.
✓ Qualification and Validation of IT-GxP Systems.
✓ Handling of IT-QMS activity: Change Control, CAPA, Deviation & Investigation, Effectiveness check related to IT-GxP.
✓ Provide Auditing related to all IT Administration, GxP & QMS activities.
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