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Leading Quality Validation Service Leading Quality Validation Service
provider as per GAMP 5 , Annex provider as per GAMP 5 , Annex 11and 21 CFR Part 11 Compliance for 11and 21 CFR Part 11 Compliance for PLC/HPLC (Lab Instruments), PLC/HPLC (Lab Instruments), SCADA,DCS, BMS, MES, Excel, ERP SCADA,DCS, BMS, MES, Excel, ERP – SAP-NAVISION, LIMS,Computer – SAP-NAVISION, LIMS,Computer System Validation, CLINICAL System Validation, CLINICAL Research Software etc.Research Software etc.
Validation DefinationValidation Defination
Establishing documented evidenceEstablishing documented evidencethat provides a high degree of that provides a high degree of assurance that a specific process will assurance that a specific process will consistently Produce a product consistently Produce a product meeting its predetermined meeting its predetermined specifications and quality attributes.specifications and quality attributes.
URS
FS
DS IQ
OQ
PQ
URB,System
Boundary
SIA
Operational Monitoring,
SOPs
Change Control
Revalidation & Periodic
Review
Discrepancy Management
Maintenance Calibration
Program
Retirement Plan
Build
Validates
Verification ValidationDid we build the right system? Did we build the system right?
Drivers For GAMP 5 GAMP5Drivers For GAMP 5 GAMP5
Life Cycle Approach Life Cycle Approach
CompanyCompany ProfileProfile: : International WorkInternational Work
Entrepreneur’s NameEntrepreneur’s Name : K.R. VAGHELA, CEO: K.R. VAGHELA, CEOCompany Name : Infra Control SystemsCompany Name : Infra Control SystemsChinese Partner : A & M Technology Co. Ltd. Chinese Partner : A & M Technology Co. Ltd.
Sector / Industry FocusSector / Industry Focus : PHARMA/BIOTECH/MEDICAL DEVICE: PHARMA/BIOTECH/MEDICAL DEVICE
Contact DetailsContact Details :09825047998 , 9327666438:09825047998 , 9327666438: 09428820365 : 09428820365
:091-265-2357207, 091-265-6543251, :091-265-2357207, 091-265-6543251, 091-265-2785840 (Off.)091-265-2785840 (Off.)
WebsiteWebsite : : www.infraics.in www.kvstech.comEmail IDEmail ID : : [email protected], [email protected] , [email protected]
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
CompanyCompany ProfileProfile:: Entrepreneur’s NameEntrepreneur’s Name : K.R. VAGHELA: K.R. VAGHELASector / Industry FocusSector / Industry Focus : PHARMA/BIOTECH/ Medical Devices/ Clinical : PHARMA/BIOTECH/ Medical Devices/ Clinical ResearchResearch
Contact DetailsContact Details :09825047998 , 9327666438:09825047998 , 9327666438: 09428820365 : 09428820365
:091-265-2357207, :091-265-2357207, 091-265-2335840091-265-2335840
WebsiteWebsite ::www.infraics.inEmail IDEmail ID : [email protected]., : [email protected]., [email protected], , 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
05/01/2305/01/23 1010
Various Other SuportVarious Other SuportA Documented Planned Predictable Performnace. That is consistent
Validation focuses on Patient Safety, Product Quality and Data Integrity.
Electronic BMR and BPR, CAPA Tracker, Audit Tracker, Change Control Systems and Paperless Validation. FDASmart Inspection System
Headed by 26 years experienced person in Headed by 26 years experienced person 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 Pillers of the CompanyPillers of the Company
-- Mr. Kalpesh R. VaghelaMr. Kalpesh R. Vaghela- Mrs. Urmila K Vaghela- Mrs. Urmila K Vaghela
- Qualification: B.E. Electronics withQualification: B.E. Electronics with specialization in Instrumentationspecialization in Instrumentation- Having 30 years work experience Having 30 years work experience - with 22 years business experience with 22 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, Japan, Norway, include North –South America, Canada, Japan, Norway, Africa, Middle East and Far East countriesAfrica, Middle East and Far East countries
- Known to provide best value for money Known to provide best value for money
About Mr. Kalpesh R. VaghelaAbout Mr. Kalpesh R. Vaghela
CSV ValidationCSV Validation- Expert in SAP –ERP Validation, Computer Expert in SAP –ERP Validation, Computer
System Validation, SCADA Validation, Excel System Validation, SCADA Validation, Excel validationvalidation
- Laboratory Instrumentation Validation Like Laboratory Instrumentation Validation Like HPLC, GC, FTIR, Malvern, UV, Raman HPLC, GC, FTIR, Malvern, UV, Raman Spectrophotometer etc plus LIMSSpectrophotometer etc plus LIMS
- EBMR – EBPR- MES SystemsEBMR – EBPR- MES Systems- Track and Trace, Artwork SoftwareTrack and Trace, Artwork Software- ASRS & WMSASRS & WMS
Expert Trainer for CSV & Data Expert Trainer for CSV & Data IntegrityIntegrity
- Expert compliance Trainer with Data Integrity, Expert compliance Trainer with Data Integrity, Data Governance, 21 CFR part 11 Compliance, Data Governance, 21 CFR part 11 Compliance, Annex 11, GAMP5, Risk Assessment, Annex 11, GAMP5, Risk Assessment, Proactive Compliance as core competence.Proactive Compliance as core competence.
- Training assignment at Emerson Process Training assignment at Emerson Process Management China Management China
Compliance Trainer for Muscat Pharmacy Compliance Trainer for Muscat Pharmacy Trained Team of Alembic, Cipla, Lupin, SUN, Trained Team of Alembic, Cipla, Lupin, SUN,
Glenmark, Watson, Naproad, Sentiss Etc. Glenmark, Watson, Naproad, Sentiss Etc.
Open Training Session Open Training Session Open Training Session conducted at Open Training Session conducted at Mumbai Mumbai Hyderabad Hyderabad Chandigarh etc..Chandigarh etc..
Select Important Clients Select Important Clients Horiba Scientific Lille, FranceHoriba Scientific Lille, France Muscat Pharmacy Oman Muscat Pharmacy Oman Emerson Process Management Shanghai, ChinaEmerson Process Management Shanghai, China Elly Lilly Singapore Staff Elly Lilly Singapore Staff Mylan Mylan Glenmark Glenmark WatsonWatson
Alembic Alembic CiplaCipla Naproad Life SciencesNaproad Life Sciences Sentiss Pharma Sentiss Pharma Pirmal GlassPirmal Glass Nootan PharmaNootan Pharma
Lupin Lupin S Kant S Kant Dr Reddy’s lab Dr Reddy’s lab Unique Pharmaceuticals Unique Pharmaceuticals UnimedUnimed
Sun PharmaceuticalsSun Pharmaceuticals Degina Medical DevicesDegina Medical Devices HCL TechnologiesHCL Technologies Synegene Biocon Group companySynegene Biocon Group company MphesiSMphesiS Alkem Alkem Piramal Piramal
Foreign CSV ProjectsForeign CSV Projects Porton China Porton China Premier Validation Premier Validation Morton GroovesMorton Grooves Emerson China Emerson China Muscat Pharmacy Muscat Pharmacy Horiba Scientific FranceHoriba Scientific France Actavis Iceland Actavis Iceland
ExpertiseExpertise Worked on Many Project of Pharma Company.Worked on Many Project of Pharma Company. Audit Support for USFDA, MHRA, MCC, TGA, Audit Support for USFDA, MHRA, MCC, TGA,
ANVISAANVISA Considered to be Expert in Validation, GAP Considered to be Expert in Validation, GAP
Analyses, Risk Assessment, 21 CFR Part 11 Analyses, Risk Assessment, 21 CFR Part 11 Compliance and Training.Compliance and Training.
All Leading Indian & MNC Companies are our All Leading Indian & MNC Companies are our Clients.Clients.
International work Experience in Europe, USA, International work Experience in Europe, USA, China, Africa and Middle East.China, Africa and Middle East.
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, Biotechnology and Medical Instrument industryPharma, Biotechnology and Medical Instrument industry- Validation helps reduce the Business risk , the Product Validation helps reduce the Business risk , the Product
Quality Risk as well as implement Good Manufacturing Quality Risk as well as implement Good Manufacturing Practices 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- MES/DCS/SCADA/ BMS/EMS- MES/DCS/SCADA/ BMS/EMS- SAP R3 ERP, Navson Dynamic NAV, Pharma Suite, BASE- SAP R3 ERP, Navson Dynamic NAV, Pharma Suite, BASE- Inventory Management Software- Inventory Management Software- Computer System, PC Validation- Computer System, PC Validation- Excel Sheet, Network Qualification, Infra Structure Qualification- Excel Sheet, Network Qualification, Infra Structure Qualification
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. Emerson, Sauter, Honeywell, Siemens, - BMS Validation System. Emerson, Sauter, Honeywell, Siemens, JohnsonsJohnsons
Related ServicesRelated Services- 21 CFR Part 11 Compliance Audit , Training- 21 CFR Part 11 Compliance Audit , Training- IT Infrastructure Qualification- IT Infrastructure Qualification- 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 GAP AnalysesGAP Analyses Annex 11 Compliance.Annex 11 Compliance.
FOREIGN CLIENTSFOREIGN CLIENTS Premier Validation Premier Validation KNEAT IrelandKNEAT Ireland Morton Grove Pharmaceuticals Inc.- ChicagoMorton Grove Pharmaceuticals Inc.- Chicago Horiba Scientific Japan in FranceHoriba Scientific Japan in France EMERSON Process Control Company ChinaEMERSON Process Control Company China Muscat Pharmacy OmanMuscat Pharmacy Oman Actavis Iceland Actavis Iceland
Foreign Tie UpForeign Tie Up Premier Validation- UK, EuropePremier Validation- UK, Europe Kneat – IrelandKneat – Ireland A & M Technology Company Ltd. ChinaA & M Technology Company Ltd. China Chinmoy Roy Independent Pharma Chinmoy Roy Independent Pharma
ConsultantConsultant
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 CEO. Staff and CEO.
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.
Alembic Training Two SessionAlembic Training Two Session
Divinne Group InternationalDivinne Group International
Naproad Life Sciences Pvt. Ltd.Naproad Life Sciences Pvt. Ltd.
SENTISS Pharma Pvt. Ltd. SENTISS Pharma Pvt. Ltd.
WORDS OF APPRECIATION…WORDS OF APPRECIATION…
What MAKE US THE BEST ?What MAKE US THE BEST ?
27 years of Pharma Experience at your Service27 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 –On Real talented staff and they are being trained often –On job and Off job training with technical and job and Off job training with technical and motivational aspectsmotivational 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 in the Economic Times of India out of 12000 entry in the year 2009.year 2009.
Latest set of equipment with state of the art setupLatest set of equipment with state of the art setup All staff member are provided with latest All staff member are provided with latest
windows updated laptop having licensed windows updated laptop having licensed Antivirus software for protocol preparation/field Antivirus software for protocol preparation/field workwork
Allen Bradly, Mitshibishi, Baijer Software program with cable for program down load purpose
