About Company

Welcome to KVS Technologies

KVS Technologies has a strong professional experience of CSV and regulatory services in Healthcare, Pharmaceuticals and Life sciences industries to meet customer expectations. KVS was founded by Mr. Shankar Sapavadiya and Mr. KalpeshKumar Vaghela in Year 2006. Both promoters have 30+ Years of experience in the fields of Instrumentation , Automation and Validation in Pharma Industries. The main area of interest is to provide CSV and compliance services to Life science, Healthcare and Pharmaceutical Industries of India and worldwide.

KVS Team has 16+ years of experience of Validation of computerised Systems, IT Systems. We build the most effective environment for customers on current updates of 21 CFR Part 11, EU Annex11 regulatory Compliance. KVS has provided CSV and regulatory compliance services to more than 150 companies in India and worldwide in the fields of life sciences, Pharmaceuticals, Chemicals, Medical Device, cosmetics

Our Vision

is to be the best partner in Validation of Automated computerised system and IT system and regulatory compliance services for healthcare, pharmaceuticals and life sciences industries.

Our Mission

is to provide the most Intuitive , Transparent, Economical , Effective CSV and regulatory compliance services to Healthcare, Pharmaceuticals and Life sciences industries as per current regulatory requirements.

Computerised System Validation Services Provided by KVS Technologies


PartnerFor us at KVS, it’s not only about preparing documentation; We are experts in Pharma processes as well as regulatory requirements which enables us to provide perfect solutions. We provide CSV and Regulatory services as per GAMP Guidelines, 21 CFR Part 11 and EU GMP Annex 11 for following systems:


  • Automated manufacturing equipment PLC-SCADA-DCS System
  • SAP ECC 6.0 / SAP HANA / SAP HANA Cloud.
  • IT Compliance Services and Server based Systems
  • Laboratory Instruments Software Validation HPLC, GC and Laboratory Information Management.
  • Clinical Trials Data Management
  • Manufacturing Resource Planning(MRP),Enterprise Resource Planning (ERP)
  • Building Management System(BMS)/Environment Monitoring System (EMS)
  • Document Management System
  • Electronic Batch Manufacturing Records (EBMR)
  • Stability System Software
  • Vendor Assessment / Vendor Audit
  • 21 CFR Part 11 and EU GMP Annexure 11 Impact assessment.
  • Periodic review of Computerised System
  • Third party IT Audit
  • Deputing CSV /IT work force and Engineers team at site.
  • Review of CSV documents , Change Control , CAPA and other IT solutions

Mr. Shankar Sapavadiya


Founder Partner of KVS Technologies, a senior CSV consultant , Mr. Shankar Sapavadiya has an experience of 30+ years in field of Pharma Automation, Instrumentation, Projects and CSV. He started his career from Alembic Pharmaceuticals Limited in 1988 as an Instrumentation and Automation Engineer in Formulation plant. He has 30+ Years of experience for PLC, SCADA, DCS, BMS, Lab instrumentation software, EBMR, ERP software, SAP, ECC 6.0, Pharma cloud , Microsoft Dynamic NAV ,Stability software, Empower 3, Lab solution validation as per GAMP Guidelines, 21CFR Part 11 and EU GMP Annex 11.

He has successfully managed and completed CSV Projects at more than 150 API and Formulation plants of pharmaceutical companies. Some of the clients are Abbot, Alembic, Alkem ,Cipla, Dr.Reddy’s, Eisai–Vizag ,Glenmark, Gulbrandsen, Lupin, Fresenius Kabi, IPCA , Piramal Health care, Morton Grove USA, Micro Lab , Otsuka, Neuland, Mylan, Wockhardt, Ranbaxy, Watson, Sun Pharma, Unison Pharma , Zydus Cadila, etc. He has a strong track record for SAP Validation, Computer System Validation, PLC, SCADA, DCS and BMS Validation for USFDA, MHRA, WHO GMP, TGA and all the regulatory requirements


Mr. Nirav Sapavadiya


Mr. Nirav Sapavadiya has an experience of 7-8 years in field of Electrical ,Automation, Instrumentation, PLC, SCADA, DCS, BMS, Lab instrumentation software, EBMR, ERP software,Lab solution validation as per GAMP Guidelines, 21CFR Part 11 and EU GMP Annex 11.


Mr. Kalpeshkumar Vaghela


Founder Partner of KVS Technologies, a Senior CSV Consultant, Mr. Kalpeshkumar Vaghela has 30+ years of experience in field of Pharma Automation, Instrumentation, Projects and CSV. He is an Automation and Software Validation Specialist, Expert Trainer on CSV, Data Integrity, GAMP-5, 21 CFR part 11 Compliance, Annex 11, Risk assessment, Proactive CSV Approach. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve compliance by training and motivating professionals for QbD and Right First Time Approach. He has supported clients for many USFDA, MHA, ANVISA, MCC, and TGA Customer Audits as a CSV consultant.

About 11 years of work experience on high-level CSV Validation in India and Abroad has made Mr. Vaghela a Subject Matter Expert in CSV, Data Integrity Audit for Life Science. Medical Device and Clinical Research Industry.


Mr. Jaydutt Vaghela


Mr. Jaydutt Vaghela has an experience of in field of PLC, SCADA, DCS, Lab instrumentation software, ERP software,Lab software validation as per GAMP Guidelines, 21CFR Part 11 and EU GMP Annex 11.


KVS Technologies’ Team


KVS Technologies have well trained , experienced team of 18-20 Engineers. All are trained for GAMP Guidelines , 21 CFR Part 11 , EU GMP Annex 11, cGMP Requirements , GDP requirements , Instrumentation and Engineering aspects.