Atul Pawar

Background

About Atul Pawar

Experienced CSV Professional | Expertise in FDA & GAMP 5 Compliance | Data Integrity & System ValidationI have experience in the field of Instruments and Computerized System Validation (CSV) within regulated environments, ensuring compliance with FDA and GAMP 5 guidelines. My key areas of expertise include:Qualification Planning & Execution: Skilled in drafting and executing Qualification Plans, Test Plans, Test Specifications, and Qualification Reports (IQ, OQ, PQ).CSV for Software Applications: Conducted end-to-end CSV for critical applications like LabX, ICDAS Pixel Proof System, ensuring data integrity and validated state.Chromeleon 7.3.2 Report Template Validation: Supported report template validation activities by performing manual calculations of results and comparing them with software-generated data to verify accuracy and compliance.Cross-functional Collaboration: Worked closely with IT, QA, and Engineering teams to address system issues and implement improvements effectively.CAPA Management: Experienced in handling Corrective and Preventive Actions (CAPA), including impact assessment, root cause analysis, and closure documentation.Hazard and Risk Assessment (HLRA): Proficient in preparing HLRA for software and instruments, including risk categorization and functional risk evaluations.Defect Management: Experience in identifying, documenting, and resolving system-related issues during validation phases.Data Security & Restoration: Hands-on experience in ensuring system data security, backup, and restoration protocols.System Retirement & Documentation: Competent in preparing system retirement strategies and maintaining complete, audit-ready documentation.Passionate about driving quality, compliance, and continuous improvement across all aspects of system validation and lifecycle management