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.
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Kalpesh Vaghela CEO Infra Control Systems
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