Building Better Quality Systems for Regulated Industries.
Sri Harshini Vemuganti is a Senior Product Consultant specializing in eQMS, Quality Management, GxP Compliance, CAPA, Change Control, Deviations, Requirements Analysis, and User Acceptance Testing.
Focus
eQMS · GxP · Life Sciences
About Me
Sri Harshini is a Senior Product Consultant helping pharmaceutical and life sciences organizations manage compliant and efficient quality processes.
Her work focuses on functional and product consulting for the EPIQ eQMS platform, supporting organizations across critical quality workflows including CAPA, Change Control, Deviations, requirements analysis, issue investigation, client coordination, and User Acceptance Testing.
Her professional background also includes clinical research technology, with experience across EDC, eTMF, CTMS, eConsent, and RTSM systems.
This combination of quality management and clinical technology experience provides a systems-level understanding of the regulated lifecycle—from clinical research through quality management.
Core Expertise
Depth across the quality lifecycle—from requirement definition to validated release in GxP environments.
eQMS
Supporting digital quality management processes in regulated environments.
CAPA
Supporting corrective and preventive action workflows.
Change Control
Supporting controlled and compliant change management processes.
Deviations
Supporting deviation investigation and resolution workflows.
Requirements Analysis
Understanding business needs and translating them into clear functional requirements.
User Acceptance Testing
Supporting testing and validation processes before implementation and release.
GxP Compliance
Supporting regulated quality processes and helping organizations remain audit-ready.
Stakeholder Management
Coordinating effectively with clients, QA teams, business stakeholders, and technical teams.
Professional Journey
Caliber Technologies
Senior Product Consultant
Sri Harshini
Business Analyst
JNTUH College of Engineering Hyderabad
Project Intern
ICAR — Indian Council of Agricultural Research
Project Intern
Technology & Domain Expertise
Three connected clusters spanning compliance, product analysis, and clinical research systems.
Quality & Compliance
Expertise in managing electronic quality management systems, ensuring quality standards, handling CAPA, controlling changes, managing deviations, and maintaining GxP compliance.
Product & Business Analysis
Expertise in guiding product decisions, analyzing business requirements, investigating issues, managing stakeholder expectations, and ensuring solutions meet user and business requirements through testing.
CLINICAL RESEARCH TECHNOLOGY
Experience with clinical research technologies for managing trial data, essential documents, clinical operations, participant consent, randomization, and trial supply management.
Academic Background
Master's Degree
M.Sc. Microbiology
St. Francis College for Women
January 2022 – April 2024
Bachelor's Degree
Bachelor of Science – Microbiology
Kasturba Gandhi Degree & PG College for Women
September 2018 – April 2021
Certification
Mushroom Cultivation
ICH-GCP Guidelines
Professional working knowledge
Languages
English
Professional (Working Proficiency)
Hindi
Professional (Working Proficiency)
Bridging Quality, Technology & Compliance.
Understand
Understand:
- Requirements
- Processes
- Business challenges
- Quality workflows
Collaborate
Work closely with:
- Clients
- QA teams
- Business stakeholders
- Technical teams
Deliver
Support:
- Compliant solutions
- Reliable systems
- Product improvements
- Quality-driven outcomes