Manasa Rampally

Led computer system validation for a rotary vial washer, producing audit-ready URS, IQ/OQ/PQ protocols, risk assessment, and validation deliverables aligned with 21 CFR Part 11 and GAMP 5. Authored and executed a CSV addendum protocol for Part 11 compliance gaps, including user access control, RBAC, audit trail, and electronic record protection testing. Validated Wonderware InTouch SCADA/HMI and key GxP infrastructure on VMware ESXi/vCenter, performing data integrity assessments and documenting remediation and audit readiness artifacts.

Used Kneat Gx to author, execute, and maintain validation documentation with traceability across CSV and equipment qualification projects. Performed IQ/OQ execution for CTUs, refrigerators, cold rooms, and incubators, and led stability chamber qualification with temperature mapping using Kaye Validator and wireless data loggers. Coordinated FAT/SAT activities with vendors, created validation master plans and FMEA-based risk assessments, and managed TrackWise CAPA/deviation and change-control closure workflows to support audit readiness.

Executed CSV lifecycle activities for enterprise systems including CAMSTAR, CIM, and LIMS, delivering URS/FRS, DS/IOQ protocols, RTM, UAT, and validation summary reporting aligned with 21 CFR Part 11 and GAMP 5. Managed LIMS validation administration, including software requirements, test cases, user access controls, and data backup/archiving procedures. Validated software on analytical laboratory instruments and strengthened data integrity controls through audit-trail verification standardization and CAPA-driven documentation improvements.

Performed commissioning and IQ/OQ/PQ validation for automated systems, including bioreactors and autoclaves, focusing on PLC logic and HMI software verification against approved specifications. Developed validation documentation such as SRS, RTM, and validation summary reports for control and monitoring systems to ensure GMP traceability. Conducted thermal mapping for relevant equipment and supported compliant change-control and risk assessment for utility and process systems, partnering with vendors for FAT/SAT execution and documentation reviews.