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Dear Sir,

We at Infra Control system are fully dedicated in helping Pharmaceutical, Medical Device
manufacturer and Biotechnology company get through the Most stringent regulatory requirements
and approval for audits like US FDA, MHRA, TGA etc..

We carry out following activity which is related to GAMP 5, 21 CFR part 11 compliance

I as CEO of Infra Control Systems have great pleasure to inform you that Every day we are adding
new clients from some part of the world for Software Validation. We are expert on ICH Q9 Risk
Assessment and Risk management. Reduce your CAPA, Change control and focus more on the
Quality Production and Training. We also have good package of Electronic EBMR, EBPR, Paperless
Validation for big growing company.

We have successfully worked in USA, Europe, Ireland, China, South Africa and now gearing up to
serve the whole world. Best quality services at reasonable price and true positive surprise to client
by the quality and accuracy is our motto. If you are looking for the good partner who can help you in
producing quality product, it is a time to give us a call at +919825047998. Write to
infraics@yahoo.com.

Most important job we can do for you is ERP, BMS,SCADA, PLC , Computer Systems and Laboratory
Instruments Validation.


Services We provide
Infra Control Systems Provides Quality Validation, Services to the Pharmaceutical,
Biotechnology and Medical Device Industries. We have the team of talented and
committed people to take care and provide excellent services for all type of regulatory
requirements.

We offer a full list of services such as Software Validation of Computer System, HPLC –
PLC , DCS-SCADA , SAP-ERP Software, BMS. Training and 21 CFR Part 11 Compliance
Audit and much more. Quality Validation Work, complete responsibility from start to
finish, personalized support and the success of your projects at best price are the
foundation of our company.


Facility Qualification
Equipment Qualification
IT Infrastructure Qualification
Regulatory compliances Services
PLC - Programmable Logic Controllers Validation
DCS / SCADA Validation
SAP R/3 ERP Validation
PC Validation
Excel Sheet , Network Validation
Lab Equipments Validation
HPLC, GC, FTIR, Stability Chamber Software - Enviro Validation
Laboratory information Management System ( LIMS)
Computer System Application Software Validation
BMS Validation System - Sauter, Honeywell, Siemens, Johnsons
Clinical Research Software Validation
Clinical Trial Application Software, PE Access
SAS, Win Non Lin, Application Software Validation
Preparation of SOPS
Third Party Vendor Audit
Third Party Company Audit
Annex 11 Audit

RELATED SERVICES

Electronic BMR and BPR
21 CFR Part 11 Compliance Audit
Training for GMP, GAMP4-5, 21 CFR Part 11 Compliance, Annex 11
Humidity Temp. Profiling
Calibration of Process Instruments
Pharma Process Data Monitoring and Control
Display Systems
Customised Plant Automation
Dataloggers for Pharma Application




To Help you better Please provide following inputs



No of machines you have with PLC, SCADA, DCS on production floor

No of PC used in Quality Department

Details of ERP/ LIMS being used by you.

Details of BMS system if you have

Details of Laboratory instruments you have.




Wishing you a very great and wonderful day.
Thanking you. Assuring you of best services.


------------------------------------------------------

Kalpesh Vaghela CEO        Infra Control Systems
------------------------------------------------------
Your Quality Automation & Validation Partner
-------------------------------------------------------
Mob : 98250 47998, 8758217198, 9327666438
Alternate Mobile : 9428820365
Ph: 091265: 2785840 / 2357207
Fax: 0265-2357207
Skype: kalpesh706, kvstechnologieskrv
-------------------------------------------------------
Web: www.infraics.in, www.kvstech.com
-------------------------------------------------------
Email : infraics@yahoo.com / infraics@gmail.com

Office at China : Nanjing Road, Shanghai
Vadodara, Goa, Baddi.
---------------------------------------------------------------------

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Ics intro letter

  • 1. Dear Sir, We at Infra Control system are fully dedicated in helping Pharmaceutical, Medical Device manufacturer and Biotechnology company get through the Most stringent regulatory requirements and approval for audits like US FDA, MHRA, TGA etc.. We carry out following activity which is related to GAMP 5, 21 CFR part 11 compliance I as CEO of Infra Control Systems have great pleasure to inform you that Every day we are adding new clients from some part of the world for Software Validation. We are expert on ICH Q9 Risk Assessment and Risk management. Reduce your CAPA, Change control and focus more on the Quality Production and Training. We also have good package of Electronic EBMR, EBPR, Paperless Validation for big growing company. We have successfully worked in USA, Europe, Ireland, China, South Africa and now gearing up to serve the whole world. Best quality services at reasonable price and true positive surprise to client by the quality and accuracy is our motto. If you are looking for the good partner who can help you in producing quality product, it is a time to give us a call at +919825047998. Write to infraics@yahoo.com. Most important job we can do for you is ERP, BMS,SCADA, PLC , Computer Systems and Laboratory Instruments Validation. Services We provide Infra Control Systems Provides Quality Validation, Services to the Pharmaceutical, Biotechnology and Medical Device Industries. We have the team of talented and committed people to take care and provide excellent services for all type of regulatory requirements. We offer a full list of services such as Software Validation of Computer System, HPLC – PLC , DCS-SCADA , SAP-ERP Software, BMS. Training and 21 CFR Part 11 Compliance Audit and much more. Quality Validation Work, complete responsibility from start to finish, personalized support and the success of your projects at best price are the foundation of our company. Facility Qualification Equipment Qualification IT Infrastructure Qualification Regulatory compliances Services PLC - Programmable Logic Controllers Validation DCS / SCADA Validation SAP R/3 ERP Validation PC Validation Excel Sheet , Network Validation Lab Equipments Validation HPLC, GC, FTIR, Stability Chamber Software - Enviro Validation Laboratory information Management System ( LIMS)
  • 2. Computer System Application Software Validation BMS Validation System - Sauter, Honeywell, Siemens, Johnsons Clinical Research Software Validation Clinical Trial Application Software, PE Access SAS, Win Non Lin, Application Software Validation Preparation of SOPS Third Party Vendor Audit Third Party Company Audit Annex 11 Audit RELATED SERVICES Electronic BMR and BPR 21 CFR Part 11 Compliance Audit Training for GMP, GAMP4-5, 21 CFR Part 11 Compliance, Annex 11 Humidity Temp. Profiling Calibration of Process Instruments Pharma Process Data Monitoring and Control Display Systems Customised Plant Automation Dataloggers for Pharma Application To Help you better Please provide following inputs No of machines you have with PLC, SCADA, DCS on production floor No of PC used in Quality Department Details of ERP/ LIMS being used by you. Details of BMS system if you have Details of Laboratory instruments you have. Wishing you a very great and wonderful day. Thanking you. Assuring you of best services. ------------------------------------------------------ Kalpesh Vaghela CEO Infra Control Systems ------------------------------------------------------
  • 3. Your Quality Automation & Validation Partner ------------------------------------------------------- Mob : 98250 47998, 8758217198, 9327666438 Alternate Mobile : 9428820365 Ph: 091265: 2785840 / 2357207 Fax: 0265-2357207 Skype: kalpesh706, kvstechnologieskrv ------------------------------------------------------- Web: www.infraics.in, www.kvstech.com ------------------------------------------------------- Email : infraics@yahoo.com / infraics@gmail.com Office at China : Nanjing Road, Shanghai Vadodara, Goa, Baddi. ---------------------------------------------------------------------