Services
Our Services
Infra Control Systems is a 22 year old leading Automation and Validation Company of India which is engaged in Software validation, GAP Assessment, Data Integrity Audit, Remediation for CSV and Training on various Subject related to Pharma Compliance. We are a leading CSV Consultant of India working all round the world.
Our rich experience on CSV and Data Integrity Compliance can help Large, Medium and Small Pharma Companies to gain out of it and remain compliant in specified budget.
We can help you a lot in current situation when most Pharma Company are getting 483- Warning Letters on Data Integrity and CSV front. Prevention is always better then cure and less expensive also. Good CSV can help you Reduce CAPA, Change Control, Batch Recall and give all people (Patient- Share holder and staff) a good Peace of mind. Patient safety, Product Quality and Data Integrity is a key focus of Regulatory Audits.
60% of Top Indian Pharma Company is client of Infra Control Systems or KVS Technologies. Good care needs to be taken while selecting the Software validation consultant in checking their Facility, Company Management, Mission- Vision, Ranking Industry wise and Pharma Sector Wise, Experience of working with Top companies of the world. It helps to be with the leader.
Please visit company website www.kvstech.com and www.infraics.in and you will see references from all top people of Pharma Industry. We try to focus on Seven Habits of Highly Compliant Companies.
Our Expertise
- 1) Computer Systems Validation for Manufacturing / Laboratory Instruments – PLC, SCADA, BMS, MES,LIMS , ERP, EBMR-EBPR, DMS-LMS
- 2) CSV for Excel Validation, Clinical Research Software
- 3) Data Integrity Audit and GAP Analysis for 21 CFR Part 11 Compliance and Annex 11 Compliance, Third Party Vendor Audit, FAT- SAT for Equipment
- 4) Remediation for CSV- DATA Integrity related issues.
- 5) Fool proof System owner job of validation like Data Integrity, Backup – restoration, Archival- retrieval – Data Retention and Migration check.
- 6) Compliance Training on Why Validation? , Role of FDA, 21 CFR part 11 Compliance, Annex- 11, ALCOA+, GAMP5, Risk Assessment, CSV Deliverables, Data Integrity, Learning from recent and old 483- Warning letters.
Training part is of ultimate importance on which many company do not focus. It is a known fact that if all staff is given training on Data Integrity and Compliance the return to the company will increase by Multifold. We see stock price crashing down on receipt of 483 or warning letter.
We have successfully worked in USA, Europe, France, Iceland, China, Middle East (Oman, Saudi Arabia, IRAN) and now gearing up to serve the whole world in a big way.
Best quality services at reasonable price, true positive surprise to client by good quality, accurate and timely work 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, 8320551508, 8758217198. Write to infraics@yahoo.com, kvstech7@yahoo.co.in
You can trust us for USFDA, MHRA, TGA, ANVISA, MCC and other critical Audit.
International client list Includes Giants like
- Emerson process Management- China BMS/EMS Validation and Training
- Horiba –yuovn Scintific - Japan –France Raman Spectroscopy Lab Spec Suite GAP Assessment
- Muscat Pharmacy – Biggest Retail chain of Middle East for Pharma- Food- Medical devices – ERP Validation
- Cigalah – Saudi Arabia Biggest Retail chain of KSA for Pharma- Food- Medical Devices – ERP Validation
- Morton Grooves - Chicago Il USA- SOPS and Go Live SAP
- Watson Iceland - GRC Software for SAP
- Pharma Green Sys IRAN - International Conference
- Premier Validation U.K – Online sale of Validation Documents