Computer System Validation • Life Sciences

Srinivas Kondeti

Senior Computer System Validation Professional

CSV / CSA professional with 8+ years of experience delivering compliant computerized system implementations, validation programs and production support within regulated pharmaceutical and life sciences environments.

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8+ Years Experience
35+ Implementations
Global US • UK • Asia
GxP Regulated Systems
Srinivas Kondeti
CSV / CSA Life Sciences Professional
Professional Profile

Validation expertise built around quality and compliance.

I bring more than eight years of professional experience in computer system validation, software implementation and product support within regulated pharmaceutical environments.

My experience covers the computerized system lifecycle from requirements and risk assessment through configuration, validation testing, deployment and ongoing production support.

I have worked with global cross-functional teams across the United States, United Kingdom and Asia, partnering with QA, business users, technical teams and vendors to deliver compliant and sustainable solutions.

Professional Highlights

✓ 35+ computerized system implementation projects
✓ End-to-end CSV lifecycle experience
✓ GxP pharmaceutical and life sciences environments
✓ Global stakeholder and cross-functional team leadership
✓ Audit readiness, deviations, change control and CAPA
Core Expertise

Computer System Validation & Software Assurance

Experience supporting risk-based validation and compliance activities throughout implementation, testing, deployment and ongoing system operation.

CSV

Computer System Validation

Validation planning, requirements, risk assessment, testing, traceability and validation reporting.

CSA

Computer Software Assurance

Risk-based assurance approaches focused on patient safety, product quality and intended use.

RA

Risk-Based Validation

Functional risk assessment, testing strategy, mitigation and regression scope determination.

QA

Quality & Compliance

Deviation management, CAPA, change control, inspection readiness and audit support.

Regulatory Knowledge

Compliance Frameworks

Practical experience supporting validation activities in regulated pharmaceutical and life sciences environments.

GAMP 5 21 CFR Part 11 EU Annex 11 GxP CSV CSA Risk Assessment Data Integrity Electronic Signatures Audit Trails Change Control CAPA Deviation Management Audit Readiness
Validation Lifecycle

End-to-End CSV Lifecycle

Experience supporting computerized systems from validation planning through production release and continued compliance.

01 Validation Plan
02 URS
03 Risk Assessment
04 FS / Configuration
05 IQ
06 OQ
07 PQ / UAT
08 Traceability
09 Validation Report
10 Go-Live
Career Journey

Professional Experience

Progressive experience across validation, product consulting, implementation and regulated software support.

Senior Product Specialist

Caliber Technologies Pvt. Ltd.
  • Led and supported computerized system implementations within regulated pharmaceutical environments.
  • Coordinated with QA, business, technical and vendor teams throughout validation and deployment.
  • Supported global projects across the United States, United Kingdom and Asia.
  • Managed validation, configuration, UAT, SAT, production deployment and post-go-live activities.

Product Consultant / Senior Product Consultant

Caliber Technologies Pvt. Ltd.
  • Supported requirements gathering, system configuration, validation testing and user training.
  • Prepared and executed IQ, OQ, PQ and UAT documentation.
  • Supported deviation investigation, change management and production issues.

Validation Engineer

Caliber Technologies Pvt. Ltd.
  • Prepared validation plans, URS, functional specifications, risk assessments and traceability documentation.
  • Executed validation protocols and documented validation evidence.
  • Supported compliant system implementation and release activities.
Systems Experience

Regulated Enterprise Systems

eQMS

Quality Management Systems

Quality workflows, CAPA, change control, deviations and regulated processes.

EDMS

Document Management Systems

Controlled documents, review workflows, approvals and document lifecycle management.

LIMS

Laboratory Information Management

Computerized laboratory systems supporting regulated quality environments.

TMS

Training Management Systems

Employee training, qualification, assignments and compliance tracking.

Global Experience

Working Across Global Teams

🇺🇸

United States

Pharmaceutical system implementation, validation, production support and stakeholder collaboration.

🇬🇧

United Kingdom

On-site implementation, validation, system testing, training and stakeholder coordination.

🌏

Asia & International

Multi-site computerized system implementations and regulated software deployment support.

Let's Connect

Interested in working together?

I am interested in Computer System Validation, Computer Software Assurance and regulated computerized system opportunities within the pharmaceutical and life sciences industries.

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