10/12/2026 updated
100 % available
Computer system validation, GXP, 21 CFR PART 11, Pharma, Life sciences
New Delhi, India
Only remote
About me
Krishna Bansal is a Computer System Validation (CSV) and Computer Software Assurance (CSA) professional with 3 years of experience supporting the pharmaceutical, biotechnology, and life sciences industries.
Title 21 of the Code of Federal RegulationsComplianceData ValidationPharmaceutical EngineeringCode of Federal RegulationsSoftware-VerifikationGXP
Krishna Bansal | Computer System Validation (CSV) & Computer Software Assurance (CSA) Professional
Krishna Bansal is a Computer System Validation (CSV) and Computer Software Assurance (CSA) professional with 3 years of experience supporting the pharmaceutical, biotechnology, and life sciences industries. He has knowledge of GxP compliance, computerized system validation, quality assurance, risk-based validation, and regulatory requirements for computerized systems used in regulated environments.
Her areas of expertise include FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5 guidelines, ALCOA+ data integrity principles, electronic records, and electronic signatures. He understands the computerized system validation lifecycle, System Development Life Cycle (SDLC), and risk-based approaches to ensuring systems remain compliant throughout their operational lifecycle.
Core Skills and Competencies
Computer System Validation (CSV) and Computer Software Assurance (CSA)
GxP Compliance, including GMP, GCP, and GLP
FDA 21 CFR Part 11 and EU GMP Annex 11
GAMP 5 and risk-based validation methodologies
Data Integrity, ALCOA+, and electronic records management
Validation documentation, including URS, FS, DS, and validation plans
Risk Assessments, Impact Assessments, and Requirements Traceability Matrix (RTM)
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
User Acceptance Testing (UAT), test scripts, test execution, and evidence documentation
Change Control, Deviation Management, CAPA, and Quality Management Systems (QMS)
Periodic Reviews, Audit Readiness, and System Retirement
SaaS Applications, Cloud Systems, and Pharma IT Compliance
Krishna is interested in contributing to CSV/CSA projects, validation lifecycle activities, computerized system compliance, and quality assurance initiatives. His professional focus is on supporting reliable, compliant, and risk-based technology solutions that align with pharmaceutical regulatory expectations and data integrity requirements.
she welcomes opportunities to collaborate with pharmaceutical companies, life sciences organizations, and consulting teams on validation and compliance projects.
Experience
Professional experience0 - 5 years
Freelancer since2021
Languages
EnglishGood