Ratna Thummala
IT Quality & Compliance SME | Auditing & Computer System Validation | GxP,SOX & Privacy | Vendor Performance Oversight | Project management | Site validations and Acquisitions
- Role
- Information Technology Compliance Auditor at IQVIA
- Location
- Clayton, NC, US
- LinkedIn followers
- 500 followers
About Ratna Thummala
Experience in IT systems Quality & compliance, Computer system validation (CSV/CSA), Risk Management, Audit management (FDA, EMA, MHRA and PMDA) and Regulatory Compliance experience (GMP, GCP, ICH, GLP, Part11 and EUMDR) in Pharmaceutical, Healthcare & Life Sciences Industries.• Extensive knowledge on regulations (GMP, GLP and GCP etc.) guidelines and best practices, 21 CFR Part 11. SDLC, Infrastructure Management Services, quality risk management methodology by ICH Q9, computer system validation requirements, Audit compliance and regulatory Inspection Support.• Having the domain knowledge and hands on experience in validation of IT systems (V Cycle, and Agile) for all GAMP categories, IT Infrastructure, process control systems, manufacturing equipment and Laboratory Instruments, QMS (Lotus Notes, Trackwise / Smartsolve), Vendor qualifications and Trainings.• Worked on multiple validation projects o Pharmaceutical Industry: SAP R/3 Enterprise 6.0, Manufacturing Execution system PAS|X v2.0, Laboratory information management system, Engineering systems (BMS, EMS, PLA and SCADA).o Clinical Research Organization: CTMS, eTMF(wingspan), Centralized monitoring Argus safety database, Medidata Rave and SAS etc. involved in qualifying these applications and provided guidance in to IT compliance management.
Experience
Information Technology Compliance Auditor
Feb 2025 — Present · US
Education
Jawaharlal Nehru Technological University
B.Tech
Skills
- Fda
- Glp
- Gmp
- Change Control
- Validation
- Scada
- Computer System Validation
- 21 Cfr Part 11
- V&V
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