I will provide end to end CSV consultation

India

I speak Bengali, English, Hindi

I have 3 years of experience in the pharmaceutical and IT sectors with core of end to end CSV, QMS with great knowledge about Quality assurance and Production activities. Currently i am working on the...

About this Gig

Get expert Computer System Validation (CSV), QMS documentation, and audit-ready compliance support for your GxP-regulated systems. Im Megh Bose, a 3+ year CSV & QMS Consultant, delivering clear, compliant, and traceable documentation aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q-series, and industry best practices.

I provide:

URS/FRS, validation plans, RTMs, IQ/OQ/PQ test scripts

Evidence-backed test execution & summary reports

Risk assessments, SOPs, data integrity reviews

Audit preparation, gap analysis & documentation cleanup

Technical/literature writing for scientific or process topics

I support pharma, biotech, medical devices, SAP S/4HANA, SAP ATTP, QMS tools, LIMS, ERP and cloud systems.

If you need accurate, audit-proof documentation, or full CSV/QMS project support, Im here to help. Lets make your system fully compliant.