HARI KRISHNA CHAKALI

Gxp & Non Gxp software's validation:

• Proven ability to learn quickly and adapt to new situations.
• Skilled at working independently and collaboratively in a team environment.
• Interact with businesses and clients to understand and gather business requirements; proactively propose solutions for CSV projects that will add value to the company.
• Assisted with day-to-day operations, working efficiently and productively with all team members.
• Managed time efficiently in order to complete all tasks within deadlines.
• Responsible for preparing and/or reviewing all levels of CSV validation deliverables, such as Validation Plans, User Requirement Specifications, Initial Risk Assessment, Functional Specifications, Design Specifications, Configuration Documents, FRA, Qualification Documents, and Test Specifications (IQ, OQ, PQ Test scripts), Traceability Matrices, Gap Assessments, and Risk Analysis, 21 CFR Part 11, EU Annex 11 assessments, and Validation Summary Reports, System Retirement Plan, and System Retirement Report.
• The review of high-level risk assessment includes GxP assessment, GAMP categorization, criticality assessment, ERES applicability assessment, etc.
• Experience in various Software Development Life Cycles (SDLCs), such as Waterfall, V-Model, and Agile methodology.
• Excellent experience as a Validation Specialist, and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
• Experienced in periodic review to confirm that the computerized system remains in a valid state and is compliant with regulatory and standard requirements.
• Prepare and review the data migration plan, system retirement plan, and system retirement report.
• Various models of cloud computing, such as SaaS, PaaS, and IaaS, and their validation approach.
• Responsible for participating in validation projects in adherence to applicable global regulatory requirements, company policies, and standard operating procedures.
• Ensure GxP computerized systems are appropriately validated.

Gxp Software's:

• Experience in commissioning and qualification activities.
• Ability to lead initiatives, manage projects, identify process discrepancies, and proactively resolve issues, along with contingency planning.
• Played a key role in evaluating the GAP assessment, GxP assessment, and GAMP categorization between the existing system and regulatory requirements, and implementing the necessary CAPA to comply with the regulatory requirements.
• As a part of the project, for the client, we deliver the CSV deliverables of the Initial Risk Assessment (IRA), Project Validation Plan (PV), Functional Risk Assessment (FRA), IQ, OQ, PQ, Requirement Traceability Matrix (RTM), and Validation Summary report.
• Verify the vendor document, such as the User Manual, Design Specification, Functional Specification, and Configured Specification, to determine whether the required CSV information is present.
• Based on the risk assessment output, the qualification document will be prepared, executed, compiled, and reviewed.
• Execution will be performed to determine whether the software is meeting its intended use.
• Discrepancy will arise if the software is not meeting the intended use requirements.
• For closer examination of the discrepancy, RCA will be performed, and the required CAPA will be recommended.
• Maintains technical and industry knowledge by attending and participating in applicable company-sponsored training programs.
• Throughout the understanding of data integrity and ALCOA++ principles in relation to digital and paper-based validation.
• Conduct the system audit for GxP systems within the organization in accordance with the established audit schedule.
• Conduct a vendor qualification audit for suppliers of GxP software.
• Conduct an audit of the GxP system to ensure adherence to regulatory requirements.
• Engaged in both regulatory and customer audits, serving as a subject matter expert for CSV validation.

GxP Software Reviewed:

• Responsible for participating in validation projects in adherence to applicable global regulatory requirements, company policies, and standard operating procedures.
• As part of a validation, I have delivered the CSV outputs, which include the Pre-Risk Assessment, Pre-Risk Communication, IOQ Protocol, Post-Risk Assessment, Post-Risk Communication, and the Validation Summary Report.
• The review of high-level risk assessment includes GxP assessment, GAMP categorization, criticality assessment, ERES applicability assessment, etc.
• The process involves the preparation, execution, compilation, and review of deliverables, such as the IOQ Protocol.
• Rising discrepancy, investigation, and closer with necessity CAPA.

Gxp Data Governace & Reviewed:

• I have been involved in the prospective validation of the end-to-end validation.
• I have prepared and executed the Validation Plans, Risk Assessments Initial Risk assessement,Funtional Riksk Assessment,21 CFR & EU assessments and Qualification Documents (IQ, OQ, PQ).
• Responsible for reviewing all CSV deliverable specification documents: URS, DS, FS, CS.
• Responsible for reviewing CSV executable documents: IQ, OQ, PQ.
• Responsible for reviewing all Non-Executable documentsRrquirement Tracability matrix,Validation summary Report.
• Ensure GxP computerized systems are appropriately validated.
• Participate in process improvement and risk management activities for automated systems, and maintenance of a compliant, efficient, and integrated system until system retirement.
• Data integrity and ALCOA++ principles in relation to digital and paper-based validation.
• Providing guidance and support to internal teams for external and regulatory audit preparation and audit compliance.