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. |