Prashant P Email & Phone Number

•Performed GxP Assessment and applied principles of Data Integrity and GAMP5.•Authored 21 CFR Part 11 Assessment, EudraLex Assessment, Vendor Assessment, and Data Integrity Assessment.•Authored Master Validation Plan for the LABx and determined the validations deliverables for all 8 Instruments based on vendor qualification and the URS for each instrument.•Collaborated with the Lab Team to author URS for Automatic Titrators, Analytical Balances, Melting Point Instruments, pH/Conductivity Meters, and UV-Vis instruments.•Worked in the end-to-end deployment of DMS, and NewsPage applications from requirement analysis to system study, Testing, debugging, and Documentation.•Authored LABx URS including user management and Configuration of User Privileges as per Segregation Of Duties (SOD) and Functional Requirements.•Setup HP ALM for newly onboarded users with the ALM coordinator•Developed Risk Assessment for all the Functional Requirements and mitigated the risks.•Authored Test Plan with IQ, OQ protocols for the system, and PQ for each instrument integrated within LABX.•Evaluated the complete system and resolved the deviation with adequate Root Cause Analysis.•Involved in developing URS for Labware LIMS and Testing the interface with LABx.•Reviewed the Operational Qualification (OQ) test scripts of LIMS and executed Performance Qualification (PQ) activities as a concurrent project.•Coordinated with Labware LIMS core team, Project team, sub-teams, and Business representatives to ensure SLC deliverables are consistent and meet LIMS requirements and business needs.•Developed and Reviewed SOPs for the change control.•Maintained, reported, and tracked bugs in Jira/Plugin.•Coordinated with System analyst, developed and updated Requirement Traceability Matrix (RTM).•Authored System Release notes for each instrument validation and released them for business use.•Created validation summary reports for the overall activities performed in the validation.

Plainville, Connecticut, United States

•Performed GxP Assessment and applied principles of Data Integrity and GAMP5.•Authored 21 CFR Part 11 Assessment, EudraLex Assessment, Vendor Assessment, and Data Integrity Assessment.•Authored Master Validation Plan for Empower and determined the validations deliverables for all 6 Instruments based on vendor qualification and URS for each instrument.•Collaborated with the Lab Team to author URS for HPLC, UPLC, and UV-Vis instruments.•Authored Empower URS including user management and Configuration of User Privileges as per Segregation of Duties (SOD) and Functional Requirements.•Developed Risk Assessment for all the Functional Requirements and mitigated the risks.•Authored Test Plan with IQ, OQ protocols for the system, and PQ for each instrument integrated within Empower.•Assessed the complete system and resolved the deviation with adequate Root Cause Analysis.•Involved in developing URS for Labvantage and Testing the interface with Empower.•Reviewed the Operational Qualification (OQ) test scripts of Labvantage and executed Performance Qualification (PQ) activities as a concurrent project.•Coordinated with Labvantage core team, Project team, sub-teams, and Business representatives to ensure SLC deliverables are consistent and meet Labvantage requirements and business needs.•Developed and Reviewed SOPs for the change control.•Coordinated with System analyst, developed and updated Requirement Traceability Matrix (RTM).•Authored System Release notes for each instrument validation and released them for business use.•Created validation summary reports for the overall activities performed in the validation.

Maharashtra, India

•Ensured that the Master Service Agreement (MSA) defines the scope of services provided by Veeva Promomats for the Medical Legal and Regulatory process. This includes specific functionalities, features, and compliance requirements expected. Outline the roles and responsibilities of both parties, including Veeva's obligations regarding system maintenance, support, and updates.•Developed Service Level Agreements (SLAs) with measurable metrics to monitor the performance of Veeva Promomats. Define KPIs such as system uptime, response time for support tickets, resolution time for issues, and compliance with regulatory requirements.•Reviewed the Quality Agreement with the audit team to ensure that the compliance and validation requirements for Veeva Promomats are addressed.•Performed 21 CFR Part 11, EudraLex, and Data Integrity Assessments•Authored validation documentation, including validation plans, URS, Configuration and protocols, and reports, to demonstrate the system's compliance with regulatory standards such as FDA 21 CFR Part 11. •Included provisions for periodic audits and inspections to verify compliance with regulatory requirements.•Reviewed and modified existing Standard Operating Procedures (SOPs) for Change Control and Testing. •Responsible for analyzing and reviewing validation deliverables Functional Requirement Specifications, and System Design Specification.•Collaborate with IT and system administrators to configure Veeva Promomats MLR according to the company's requirements, including User Roles, Permissions, Workflow, and Document types.•Developed change control documentation such as Change Request Forms (CRFs), Change Control Implementation Plan, and Change Control Summary Report.•Wrote and was instrumental in approving the Requirement Traceability Matrix (RTM).•Conduct post-implementation validation activities like Admin SOP, Business SOP, and data migration to confirm the continued compliance and performance of Veeva Promomats MLR.

Mumbai, Maharashtra, India

•Participated in the vendor qualification of Veeva as a supplier and performed GxP Assessment.•Conducted a thorough analysis of User requirements and Business needs for the deployment of Veeva eTMF and CTMS systems, ensuring alignment with regulatory requirements 21 CFR Part 11, ICH E6 (R2) for Good Clinical Practice (GCP).•Developed validation plan outlining the strategy, scope, timelines, and resources required for validating Veeva eTMF and CTMS as SaaS solutions, adapting to evolving project needs.•Performed GxP Assessment, 21 CFR Part 11 assessment, and Data Integrity assessment.•Perform risk assessments to identify and mitigate potential risks associated with deploying Veeva eTMF and CTMS systems, ensuring proactive risk management throughout the project lifecycle.•Develop agile validation protocols, including Operational Qualification (OQ), and user acceptance testing protocols, tailored to the usage scenarios.•Implement testing strategies, including integration testing, to validate the functionality, performance, and compliance of Veeva eTMF and CTMS systems.•Ensure the accuracy, integrity, and security of data migration processes, guaranteeing the smooth transfer and preservation of existing clinical trial data within Veeva eTMF and CTMS systems.•Establish agile change control processes to manage changes to Veeva eTMF and CTMS configurations, updates, and enhancements, maintaining validation and compliance integrity in an environment.•Generated validation documentation, including test scripts, test results, deviations, and summary reports, to provide transparent and auditable evidence of compliance with regulatory standards and internal requirements.•Provided training and support to end users, administrators, and stakeholders on the usage and management of Veeva eTMF and CTMS systems, to meet evolving needs.

Mumbai, Maharashtra, India

•Reviewed vendor-executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols for UPLC and ensured compliance with regulatory requirements. •Developed individual User Requirements Specifications for the UPLC and Empower.•Executed GxP Assessment, 21 CFR Part 11 assessment, and documented GxP applicability.•Developed User Requirement Specifications (URS) for the Empower software and ensured that the integration points were covered. •Conducted risk assessments to identify and mitigate potential risks associated with the UPLC instrument system as a standalone. System.•Developed Wrapper Protocol to challenge requirements that are not covered by the vendor qualification including User access, privileges, saving of data, and security of individual systems.•Ensured compliance with regulatory standards such as FDA 21 CFR Part 11 and EU GMP Annex 11 throughout the qualification process, maintaining data integrity and traceability for auditable records.•Maintained documentation of validation activities, including protocols, test results, deviations, and summary reports, under company procedures and regulatory requirements.•Collaborated with cross-functional teams including Quality Assurance, Manufacturing, and Laboratory Operations to ensure alignment and coordination of validation activities with overall project timelines and objectives.•Assisted in the development of the System Admin SOP and business SOP for each standalone system.

Master Of Business Administration - Mba, Marketing

Postgraduate Degree, Applied Analytical Chemistry

Bachelor Of Science - Bs, Chemistry