Pratistha Rai
CSV Engineer at Exact Sciences
- Role
- Csv Engineer at Exact Sciences
- Location
- El Cerrito, CA, US
- LinkedIn followers
- 500 followers
About Pratistha Rai
As CSV Engineer, I have developed a strong foundation in ensuring GxP systems meet…
Experience
Csv Engineer
Nov 2022 — Present
Ensured compliance with FDA 21 CFR Parts 11, 210, 211, and 820, integrating Good Documentation Practices (GDP) throughout the Software Development Life Cycle (SDLC)Authored, reviewed, and approved key validation documents, including Risk Assessments, Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Validation Summary Reports (VSR)Executed dry runs and validation protocols, ensuring alignment with industry standards and data integrity principles (ALCOA+)Achieved full alignment with FDA 21 CFR requirements, ensuring all equipment and systems met rigorous regulatory standardsEnsured all validation processes were well-documented and compliant with GDP, enhancing traceability and audit readinessProactively identified and resolved discrepancies during validation execution, minimizing project delays and maintaining high data integrityContributed to the successful management of CAPA and Change Control processes, fostering a culture of ongoing compliance and system optimization
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