Leading Quality Validation Services As Leading Quality Validation Services As

per GAMP 5 and 21 CFR Part 11per GAMP 5 and 21 CFR Part 11

Compliance like PLC/HPLC (Lab Compliance like PLC/HPLC (Lab Instruments), SCADA,DCS, BMS, Excel, Instruments), SCADA,DCS, BMS, Excel, ERP – SAP-NAVISION, Computer ERP – SAP-NAVISION, Computer System Validation, CLINICAL Research System Validation, CLINICAL Research Software etc.Software etc.

CompanyCompany ProfileProfile:: Entrepreneur’s NameEntrepreneur’s Name : K.R. VAGHELA and: K.R. VAGHELA and

S.P. SAPAVADIYAS.P. SAPAVADIYA

Sector / Industry FocusSector / Industry Focus : PHARMA/BIOTECH: PHARMA/BIOTECH

Contact DetailsContact Details :09825047998 (Mo), 09375969719 (Mo.:09825047998 (Mo), 09375969719 (Mo.:09428820365 (Mo):09428820365 (Mo)

:091-265-2357207, 091-265-6543251, :091-265-2357207, 091-265-6543251, 091-265-2785840 (Off.)091-265-2785840 (Off.)

WebsiteWebsite ::www.kvstech.comEmail IDEmail ID ::kvstech7@yahoo.co.in

Postal AddressPostal Address : A-9, Trilok Nagar Society 15, Pratap Gunj Society,: A-9, Trilok Nagar Society 15, Pratap Gunj Society,

Gotri-Vasna linc road Pratap Gunj, Gotri-Vasna linc road Pratap Gunj, Vadodara – 390021 Vadodara- 390002Vadodara – 390021 Vadodara- 390002

Gujarat, India Gujarat, IndiaGujarat, India Gujarat, India

Headed by 24 years experienced people in Headed by 24 years experienced people in Pharma and Automation fieldPharma and Automation field

Believe in Believe in GROWTH THROUGH EXPORTGROWTH THROUGH EXPORT Validation is the only focusValidation is the only focus Two Pillers of the CompanyTwo Pillers of the Company

- Mr. Kalpesh R. Vaghela- Mr. Kalpesh R. Vaghela- Mr. S. P. Sapavadiya- Mr. S. P. Sapavadiya

About Mr. Kalpesh R. Vaghela…About Mr. Kalpesh R. Vaghela…

- Qualification: B.E. Electronics withQualification: B.E. Electronics with specialization in Instrumentationspecialization in Instrumentation- Having 24 years work experience Having 24 years work experience - with 14 years business experience with 14 years business experience - Worked As Electronics, Computer System and Worked As Electronics, Computer System and

Instrumentation Engineer with Indian Companies as well as Instrumentation Engineer with Indian Companies as well as Overseas (6.5 years) companies in All major part of world Overseas (6.5 years) companies in All major part of world include North –South America, Canada, Norway, Africa, include North –South America, Canada, Norway, Africa, Middle East and Far East countriesMiddle East and Far East countries

- Known to provide best value for money Known to provide best value for money - Expert in SAP –ERP Validation, computer System Expert in SAP –ERP Validation, computer System

Validation, Excel validationValidation, Excel validation

About Mr. S. P. Sapavadiya…About Mr. S. P. Sapavadiya…- More than 23 years of work experience inMore than 23 years of work experience in Pharmaceuticals FieldPharmaceuticals Field- He was a Core Team member of Validation CellHe was a Core Team member of Validation Cellin Corporate Quality Engineeringin Corporate Quality Engineering- And team Member of Project Team in Alembic Limited. and executed And team Member of Project Team in Alembic Limited. and executed

projects at Alembic LIMITED at Vadodara/ Panelav Formulation projects at Alembic LIMITED at Vadodara/ Panelav Formulation PlantPlant

- Faced various International audits such as MCC, MHRA, TPD Faced various International audits such as MCC, MHRA, TPD Canada,TGA, ANVISA, USFDA, WHO GMP as well as ISO 9000.Canada,TGA, ANVISA, USFDA, WHO GMP as well as ISO 9000.

- Expertise in Vender assessments, inspection, FAT, SAT, IQ, OQ and Expertise in Vender assessments, inspection, FAT, SAT, IQ, OQ and PQ for all types Process Equipment with PLC/SCADA Controls, PQ for all types Process Equipment with PLC/SCADA Controls, BMS Software, Water System.BMS Software, Water System.

We are in service sector providing...We are in service sector providing...

- Control System Validation of Automated system used by Control System Validation of Automated system used by Pharma and Medical Instrument industryPharma and Medical Instrument industry

- Reduce the Business risk , the Product Quality Risk as well Reduce the Business risk , the Product Quality Risk as well as implement Good Manufacturing Practices as implement Good Manufacturing Practices

- Help our client to get regulatory approval to export their Help our client to get regulatory approval to export their product to Europe, USA and other regulatory marketproduct to Europe, USA and other regulatory market

- Give comfort and peace of mind to Production and quality Give comfort and peace of mind to Production and quality departmentdepartment

- Develop and Execute detailed Validation Master Plans, Develop and Execute detailed Validation Master Plans, Standard Operating Procedures, Audit Reports, Protcols and Standard Operating Procedures, Audit Reports, Protcols and Test Scripts Test Scripts

Different Areas of Services…Different Areas of Services… Regulatory Compliance Services| Validation ServicesRegulatory Compliance Services| Validation Services

- PLC-Programmable Logic Controllers- PLC-Programmable Logic Controllers- DCS|SCADA/ BMS- DCS|SCADA/ BMS- SAP R3 ERP- SAP R3 ERP- Inventory Management Software- Inventory Management Software- PC Validation- PC Validation- Excel Sheet, Network Validation- Excel Sheet, Network Validation

Lab EquipmentsLab Equipments- HPLC, GC, FTIR Stability Chamber Software- HPLC, GC, FTIR Stability Chamber Software- Laboratory Information Management System (LIMS) and Computer System- Laboratory Information Management System (LIMS) and Computer System- Application Software Validation- Application Software Validation

Equipment ValidationEquipment Validation Clinical Research Software ValidationClinical Research Software Validation

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CONTD…CONTD…

BMS SystemBMS System- BMS Validation System..Sauter, Honeywell, Siemens, Johnsons- BMS Validation System..Sauter, Honeywell, Siemens, Johnsons

Related ServicesRelated Services- 21 CFR Part 11 Services, Training- 21 CFR Part 11 Services, Training- IT Infrastructure Validation- IT Infrastructure Validation- Facility Qualification- Facility Qualification- Equipment Qualification- Equipment Qualification- Humidity Temperature Profiling- Humidity Temperature Profiling- Calibration Of process Parameters- Calibration Of process Parameters- Process Data Monitoring and Control Display- Process Data Monitoring and Control Display- Customised Plant Automation - Customised Plant Automation - Dataloggers for Pharma Application- Dataloggers for Pharma Application

CONTD…CONTD…

Clinical ResearchClinical Research- Clinical Trail Application Software, PE Access- Clinical Trail Application Software, PE Access- SAS, Win Non Lin, Application Software Validation- SAS, Win Non Lin, Application Software Validation

Preaparation of SOPSPreaparation of SOPS

Esteemed Clients are…Esteemed Clients are… Abbott Healthcare Pvt. Ltd. Abbott Healthcare Pvt. Ltd. Actavis Pharma Manufacturing Pvt. Ltd.Actavis Pharma Manufacturing Pvt. Ltd. Alkem Baddi-Daman Alkem Baddi-Daman Alembic Vadodara-Panelav –KharkhadiAlembic Vadodara-Panelav –Kharkhadi Astral Pharmaceuticals IndustriesAstral Pharmaceuticals Industries

Aziant Drug Research Solutions Pvt. Aziant Drug Research Solutions Pvt. Ltd.Ltd.

Bectochem Bectochem Bafna Pharmaceuticals Ltd. Bafna Pharmaceuticals Ltd. Bio Arc Research CentreBio Arc Research Centre Cipla Goa-Baddi-KurkumCipla Goa-Baddi-Kurkum

Dr. Reddys Lab Baddi- Hyderabad Dr. Reddys Lab Baddi- Hyderabad EISAI Pharmatechnolgy & EISAI Pharmatechnolgy &

Manufacturing Pvt. Ltd.Manufacturing Pvt. Ltd. Enem Nostrum Remedies Pvt. Ltd. Enem Nostrum Remedies Pvt. Ltd. Famy Care Limited. Bawla - SarigamFamy Care Limited. Bawla - Sarigam Fresenius Kabi Oncology Ltd. Fresenius Kabi Oncology Ltd.

Glenmark Ankleshwar-Baddi-Goa -IndoreGlenmark Ankleshwar-Baddi-Goa -Indore Golden Cross Pharma Pvt. Ltd. Golden Cross Pharma Pvt. Ltd. HEMMO Pharmaceuticuals Pvt. Ltd. HEMMO Pharmaceuticuals Pvt. Ltd. IPCA RatlamIPCA Ratlam J B Chem & Pharmaceuticals Panoli - J B Chem & Pharmaceuticals Panoli -

MumbaiMumbai Kopran Limited Kopran Limited

Lupin Pharma Ltd. Boiser-Dhabhasa-Lupin Pharma Ltd. Boiser-Dhabhasa-Mandideep-Goa-Indore Mandideep-Goa-Indore

MAC-CHEM Products India Pvt. Ltd. MAC-CHEM Products India Pvt. Ltd. Matrix Laboratory Nasik -AurangabadMatrix Laboratory Nasik -Aurangabad Marck Biosciences Marck Biosciences Meditab Specilities Pvt. Ltd.Meditab Specilities Pvt. Ltd. Medispray Laboratories Pvt. Ltd.Medispray Laboratories Pvt. Ltd.

Micro Labs Ltd. Micro Labs Ltd. Mission Vivacare Ltd Mission Vivacare Ltd Marksans Pharma Ltd.Marksans Pharma Ltd. Macleods Pharma-Daman-Baddi-Sarigam Macleods Pharma-Daman-Baddi-Sarigam Murlikrishna Pharma Pvt. Ltd. Murlikrishna Pharma Pvt. Ltd.

Naprod Life Sciences Pvt. Ltd. Naprod Life Sciences Pvt. Ltd. Neela Systems ltd. Neela Systems ltd. Neuland Laboratories LtdNeuland Laboratories Ltd OKASA PACKAGING OKASA PACKAGING Panecia Bio-Tech Panecia Bio-Tech Piramal Health Care-Baddi-Pithampur-Piramal Health Care-Baddi-Pithampur-

Bawla Bawla

Ranbaxy Baddi-Dewas-Mohali-Pontasahib Ranbaxy Baddi-Dewas-Mohali-Pontasahib Raptim Research Ltd.Raptim Research Ltd. Saga Laboratories Saga Laboratories Semler Research Center Pvt. LtdSemler Research Center Pvt. Ltd S Kant Health Care Ltd.S Kant Health Care Ltd. Solrex Pharmaceuticals CompanySolrex Pharmaceuticals Company

Sun Pharmaceuticals Halol-KharkhadiSun Pharmaceuticals Halol-Kharkhadi Thermolab Scientific Equipments Pvt. Ltd. Thermolab Scientific Equipments Pvt. Ltd. Troikaa Pharmaceuticals Ltd. Troikaa Pharmaceuticals Ltd. UCB Pvt. Ltd. UCB Pvt. Ltd. Unichem Laboratories Ltd. Unichem Laboratories Ltd. Unimark Remedies Ltd. Unimark Remedies Ltd.

Unimed Technologies Ltd. Unimed Technologies Ltd. VHB Medi Sciences Ltd. VHB Medi Sciences Ltd. Vimta Labs Ltd. Vimta Labs Ltd. Watson Pharma Ambernath-Goa Watson Pharma Ambernath-Goa Wockhardt Ankleshwar-Aurangabad-Baddi-Wockhardt Ankleshwar-Aurangabad-Baddi-

Mumbai Mumbai Wyeth Landrel Ltd Wyeth Landrel Ltd ZENERA PharmaZENERA Pharma

FOREIGN CLIENTSFOREIGN CLIENTS Premier Validation Premier Validation KNEATKNEAT South African Pharma CompanySouth African Pharma Company

Foreign Tie UpForeign Tie Up Premier ValidationPremier Validation Global PharmaceuticalConsulting LLCGlobal PharmaceuticalConsulting LLC

FeatureFeature Benefits Benefits

Facilitator for major international audit Facilitator for major international audit US FDA, MHRA, MCC, TGA etc. US FDA, MHRA, MCC, TGA etc.

Opening of bigger regulatory and Opening of bigger regulatory and Indian market so High volume and Indian market so High volume and more profit due to Better pricing.more profit due to Better pricing.

Highly trained, motivated and dedicated Highly trained, motivated and dedicated Staff and partners. Staff and partners.

Customer’s interaction is reduced. Customer’s interaction is reduced. His Business and Gxp risk is His Business and Gxp risk is eliminated to great Extent.eliminated to great Extent.

Free training on Validation to Customer Free training on Validation to Customer Staff by us.Staff by us.

System is maintained in good System is maintained in good condition Through out it’s life cycle condition Through out it’s life cycle

All instruments and machines are All instruments and machines are calibrated and validated to perform calibrated and validated to perform desired task. desired task.

Uninterrupted good quality Uninterrupted good quality production as per predetermined production as per predetermined specification under all specification under all circumstances.circumstances.

Features –Benefits of our product/serviceFeatures –Benefits of our product/service

FeatureFeature Benefits Benefits

Business Continuity, Contingency and Business Continuity, Contingency and Access control Plan is prepared Access control Plan is prepared

Customer is better prepared for all Customer is better prepared for all eventuality.eventuality.

Detailed Risk assessment is carried out Detailed Risk assessment is carried out In planning before installation. In planning before installation.

Safety, Hazard risk reduced and Safety, Hazard risk reduced and Improvement in quality Improvement in quality production, reduced rejection. production, reduced rejection.

Detailed operative and preventive Detailed operative and preventive maintenance document available maintenance document available

Reduction in maintenance and better Reduction in maintenance and better plan for Preventive maintenance plan for Preventive maintenance adhered to.adhered to.

Well laid out guideline for supplier, Well laid out guideline for supplier, Staff and internal /external auditor Staff and internal /external auditor explained explained

Improved communication between Improved communication between buyer, Supplier and auditor.buyer, Supplier and auditor.

WORDS OF APPRECIATION…WORDS OF APPRECIATION…

What MAKE US THE BEST ?What MAKE US THE BEST ?

25 years of Pharma Experience at your Service25 years of Pharma Experience at your Service Active Team leader at site and Inhouse Quality Active Team leader at site and Inhouse Quality

Department to verify all protocol by internal QA Department to verify all protocol by internal QA Team.Team.

Our protocol is in depth and up to date with current Our protocol is in depth and up to date with current guidelinesguidelines

Real talented staff and they are being trained often –Real talented staff and they are being trained often –On job and Off job training with technical and On job and Off job training with technical and motivation aspectsmotivation aspects

Selected as One the best Business Idea by The Selected as One the best Business Idea by The Economic Times of India out of 12000 entry Economic Times of India out of 12000 entry

Latest set of equipment with state of the art Latest set of equipment with state of the art setupsetup

Every staff is provided with latest windows Every staff is provided with latest windows updated laptop having licensed Antivirus updated laptop having licensed Antivirus software for protocol preparation/field worksoftware for protocol preparation/field work

Allen Bradly, Mitshibishi, Baijer Software program with cable for program down load purpose