Sireesha Manne

• Conducted root cause analysis on failed validation activities and implemented corrective and preventive actions (CAPA) to enhance future compliance and system performance
• Collaborated with cross-functional teams, including QA and IT, to identify, troubleshoot, and resolve validation-related issues in a timely and compliant manner
• Contributed to the preparation of compliance assessment reports for Laboratory Information Management Systems (LIMS), supporting audit readiness and regulatory alignment

Client: Takeda Pharmaceutical Company- Delivered validation and testing services for clinical systems, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), Decentralized Clinical Trial (DCT) platforms, and Data Warehouse systems, ensuring full GxP compliance

• Developed and executed UAT test scripts using a risk-based approach to support upgrades and study-specific configurations across EDC, IRT, and eCOA platforms
• Authored traceability matrices, functional risk profiles, and test summary reports to support regulatory audits and internal quality assessments
• Reviewed system documentation (URS, test cases, results) to ensure completeness, accuracy, and alignment with 21 CFR Part 11 and GAMP5 guidelines
• Conducted data verification and functional validation activities to ensure system accuracy, integrity, and intended use across clinical data platforms
• Collaborated with cross-functional stakeholders including QA, IT, and Project Management to resolve system defects and enhance validation effectiveness
• Participated in impact assessments for system updates, deviation management, and change control processes in accordance with SDLC and internal SOPs

Client - 2seventy Bio - Validation of LIMS Workflow for its integration with automated solution to pick and parse files and data from instrument or the source location.

• Performed Adhoc testing for the complete workflow and dry run the test scripts.

Client - Sai life sciences - Validation of an ELN

• Performed OQ Execution for various test scripts and developed test deviation reports.

Trainings: Trained with ELN, LIMS, EDC and IRT tools & systems.