Ics intro letter


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Ics intro letter

  1. 1. Dear Sir,We at Infra Control system are fully dedicated in helping Pharmaceutical, Medical Devicemanufacturer and Biotechnology company get through the Most stringent regulatory requirementsand approval for audits like US FDA, MHRA, TGA etc..We carry out following activity which is related to GAMP 5, 21 CFR part 11 complianceI as CEO of Infra Control Systems have great pleasure to inform you that Every day we are addingnew clients from some part of the world for Software Validation. We are expert on ICH Q9 RiskAssessment and Risk management. Reduce your CAPA, Change control and focus more on theQuality Production and Training. We also have good package of Electronic EBMR, EBPR, PaperlessValidation for big growing company.We have successfully worked in USA, Europe, Ireland, China, South Africa and now gearing up toserve the whole world. Best quality services at reasonable price and true positive surprise to clientby the quality and accuracy is our motto. If you are looking for the good partner who can help you inproducing quality product, it is a time to give us a call at +919825047998. Write toinfraics@yahoo.com.Most important job we can do for you is ERP, BMS,SCADA, PLC , Computer Systems and LaboratoryInstruments Validation.Services We provideInfra Control Systems Provides Quality Validation, Services to the Pharmaceutical,Biotechnology and Medical Device Industries. We have the team of talented andcommitted people to take care and provide excellent services for all type of regulatoryrequirements.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 ComplianceAudit and much more. Quality Validation Work, complete responsibility from start tofinish, personalized support and the success of your projects at best price are thefoundation of our company.Facility QualificationEquipment QualificationIT Infrastructure QualificationRegulatory compliances ServicesPLC - Programmable Logic Controllers ValidationDCS / SCADA ValidationSAP R/3 ERP ValidationPC ValidationExcel Sheet , Network ValidationLab Equipments ValidationHPLC, GC, FTIR, Stability Chamber Software - Enviro ValidationLaboratory information Management System ( LIMS)
  2. 2. Computer System Application Software ValidationBMS Validation System - Sauter, Honeywell, Siemens, JohnsonsClinical Research Software ValidationClinical Trial Application Software, PE AccessSAS, Win Non Lin, Application Software ValidationPreparation of SOPSThird Party Vendor AuditThird Party Company AuditAnnex 11 AuditRELATED SERVICESElectronic BMR and BPR21 CFR Part 11 Compliance AuditTraining for GMP, GAMP4-5, 21 CFR Part 11 Compliance, Annex 11Humidity Temp. ProfilingCalibration of Process InstrumentsPharma Process Data Monitoring and ControlDisplay SystemsCustomised Plant AutomationDataloggers for Pharma ApplicationTo Help you better Please provide following inputsNo of machines you have with PLC, SCADA, DCS on production floorNo of PC used in Quality DepartmentDetails of ERP/ LIMS being used by you.Details of BMS system if you haveDetails 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. 3. Your Quality Automation & Validation Partner-------------------------------------------------------Mob : 98250 47998, 8758217198, 9327666438Alternate Mobile : 9428820365Ph: 091265: 2785840 / 2357207Fax: 0265-2357207Skype: kalpesh706, kvstechnologieskrv-------------------------------------------------------Web: www.infraics.in, www.kvstech.com-------------------------------------------------------Email : infraics@yahoo.com / infraics@gmail.comOffice at China : Nanjing Road, ShanghaiVadodara, Goa, Baddi.---------------------------------------------------------------------