MOUNIKA POLISETTY

Validation:

• Working on LabSolutions application enhancement for FTIR instrument connectivity.
• Preparing and executing Validation Protocols, including:

URS (User Requirement Specification)

FS (Functional Specification)

CS (Configuration Specification)

FRA (Functional Risk Assessment)

TRM (Traceability Matrix)

IQ (Installation Qualification)

OQ (Operational Qualification)

PQ (Performance Qualification)

• Performing test execution, verification, and troubleshooting for instrument connectivity and application functionality.
• Ensuring accuracy, completeness, and compliance of all validation documentation per GxP, ALCOA+, and 21 CFR Part 11 requirements.
• Coordinating with instrument owners, and IT teams for environment readiness and successful validation execution.
• Supporting enhancement testing, issue resolution, and data integrity verification in both development and production-like environments.

Application Migration:

• Successfully migrated 60 instances of lab applications across multiple global sites.
• Collaborated with infrastructure, network, validation, and site teams.
• Performed pre-migration checks, installation, configuration, testing, and post-migration support.
• Delivered smooth cutovers with minimal downtime.
• Performed post-migration verification, ensuring application availability, instrument connectivity, and job scheduler functionality.
• Maintained detailed migration documentation for compliance, audits, and issue tracking.
• Troubleshot login issues, communication errors, and slowness post-migration to ensure seamless user experience.

Deployment Engineer:

• Led end-to-end deployments and installed ~70 instances of LabX, Spectrum, UV WinLab, ViCell, Tiamo, OPUS, Mastersizer, Omnic WinSotax, and LabSolutions across regulated lab environments.
• Performed IQ (Installation Qualification), OQ (Operational Qualification), and ad-hoc IQ executions for new installations, upgrades, and enhancement activities.
• Conducted data migration during version upgrades for LabX v11 and UV WinLab, ensuring complete data integrity and a smooth transition.
• Managed prerequisites, installation, configuration, licence setup, instrument connectivity, and environment readiness for application deployments.
• Coordinated deployment calls with site SMEs, instrument owners, and infrastructure teams to align dependencies and timelines.
• Ensured all deployments met compliance standards (GxP, ALCOA+), and maintained detailed documentation for qualification steps, configurations, and execution outcomes.
• Delivered deployments on time under tight project pressures.

L2 Support & Deputy Application Manager

• Worked as Primary L2 Support and Deputy Application Manager for 10+ lab applications, including LabX, Spectrum, UV WinLab, ViCell, Tiamo, OPUS, Mastersizer, OMNIC, WinSotax, and LabSolutions.
• Handled 400+ incidents and 300 service requests with zero SLA breaches throughout the support period.
• Provided application troubleshooting, log checks, connectivity support, and direct user coordination.
• Collaborated with infrastructure, network, database, and site IT teams to resolve issues efficiently.
• Assisted in Windows server patching and maintenance, coordinating scheduled maintenance windows using Comap/InPat to ensure minimal downtime and smooth execution.
• Managed user access, password resets, and permission updates.
• Prepared clear incident updates, change records, and application support documentation.
• Developed a PowerShell script to detect and auto-restart the LabX Host Service, reducing manual interventions.
• Provided weekend/on-call support, ensuring timely resolution of high-priority issues.
• Ensured GxP, 21 CFR Part 11, and ALCOA+ compliance during support activities and documentation.
• Conducted risk assessments and RCA
• Executed periodic activities, including:

1. User Access Review (UAR)

2. Technical Audit Trail Review

3. Backup & Restore validation checks

4. Incident & Problem ticket review

5. Change Management review

• Resolved application unavailability by checking services, logs, and system health.
• Troubleshot application slowness by validating server performance, jobs, network latency, and background processes.
• Diagnosed and fixed communication errors between application–instrument, application–database, and client–server.
• Addressed login failures, where some users could log in and some couldn’t, by validating user roles, AD sync, access rights, and license availability.