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Anil Palosam

CSV and Data Integrity (DI) Lead
Anil Palosam
CSV and Data Integrity (DI) Lead

CSV and Data Integrity (DI) Lead

Anil Palosam

Anil has over 10 years of experience and lead various automation, CSV and DI projects across various organisations.

Anil holds B.Pharmacy from Kakatiya University and MSc in Research, Pharmacology and Applied Biosciences from Nottingham Trent University, UK.

Anil is fully aware of GAMP 5 guidelines, FDA 21CFR Part 11 and EU GMP Annex 11 requirements for computerised systems, MHRA guidance on GxP data Integrity

Qualification of Software applications:
  • ERP: SAP HANA S4, IFS
  • QMS: TrackWise
  • LIMS: Labware, Sapphire Labvantage
  • Serialisation: TraceLink
  • CMMS: Infor, SAP PM
  • EDMS: Veeva Vault
  • Windows OS upgrades
Qualification of Automated Systems:
  • Siemens PCS7 Control System composed of Simatic hardware and TIA Portal software, WinCC based HMIs and SCADA.
  • Plant PAx DCS operated via FactoryTalk view HMI and SCADA application for Purified water utility systems.
Data Integrity (DI) and QRM:
  • DI assessments on Analytical equipment, Manufacturing and Utility control systems.
  • DI remediation activities through implementation of LAN, scheduled tasks and automatic backup process via batch file configuration.
  • Applying risk-based approach methodology to determine validation strategies during qualification/remediation activities.