20/12/2020
Infra Control Systems is a 24 year old leading automation and Compliance consultant group. Infra Control Systems has strong track record for supply of Automation products, Computer Systems Validation, GAP Assessment, Risk management, Remediation and Training for USFDA / EMEA, TGA, Canadian FDA, WHO approval and more. Infra Control Systems will like to be part of your organization growth story and associate with you in upcoming compliance projects.
We have over a hundred clients worldwide and has combine work experience of 1,008,000 man-hours. We have provided services to the Industry leaders in USA, Europe, Middle East, China, Bangladesh, Srilanka and India.
We have dedicated and trained professional team to assist you in Computer Systems Validation, Automation and Selecting good Product, Software or Trainer. Mr. Kalpeshkumar Vaghela is the CEO of the Company and also Expert Trainer cm Sr. Compliance Consultant. We have Single Focus and that is Compliance for Biotech, Pharmaceutical, Chemical and Clinical Research Industry. We can be “Your Quality Validation – Audit and Training partner for Large / Medium / Small Scale Life Science/ Clinical Research/ Medical Device Manufacturing Companies as well as OEM Machine – Software Manufacturing companies.”
We can help you focus on Patient Safety, Product Quality, Data Integrity and design a smooth process to monitor and control compliance. This will help increase your yield, profit and quality. We can help you a lot by designing all activity and protocol based on science based risk assessment and Management based on Novelty, Complexity and Risk.
Good care needs to be taken while selecting the Software validation consultant in checking their Facility – Ethics standards, Company Management, Mission- Vision, Ranking Industry wise and Pharma Sector Wise. It helps to be with the leader. 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-QMS
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, GxP Audit, Pre Audit, Remediation work.
4) Remediation for CSV- DATA Integrity related issues. Closing of GAPS and reply to FDA for 483 – Warning letter and handholding till we clear the audit.
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. Training helps invest available Time, Money and Energy resources in a better productive and fruitful way. We see stock price of life science Company crashing down on receipt of 483 or warning letter making company lose millions of Dollars.
Other Support we can provide from our group is
1) Supply Good Quality eQMS-DMS-LMS Software, Document Management, Learning Management, ERP and EBMR-EBPR.
2) Paperless Validation software
3) On line Offline Consulting
4) SOP preparation.
5) Good Quality Pharma Machinery
We have successfully worked in various parts of the world and now gearing up to serve the whole world in a big way with local partner and remotely. 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, 8200499739. Write to [email protected], [email protected] or visit www.infraics.in,
Write to us to know about select client list of International repute.
We have worked with all major top IT and Pharma Companies of India
https://www.youtube.com/user/infraics
Please visit to know more about our training programs, feedback on training, Gap Assessment, Remediation and CSV Programmes and how we can help you in good compliance
Some points from my Recent TV interview on CNBC, Ping TV network and Regulatory Day Meet with Expert panel.
https://www.youtube.com/watch?v=eMO2ouzjfaM&t=596s
https://www.youtube.com/watch?v=4mAeBZz2mRI
https://www.youtube.com/watch?v=GkfXx8FB0yA&t=70s
CSV Training feedback.
https://www.youtube.com/watch?v=3kD3zw3Ge-o&t=95s
https://www.youtube.com/watch?v=w5YGsm0NiIA&t=87s
CSV and Data Integrity Controls must for Pharma, Life Science, Clinical, Medical Device Manufacturer.
Infra Control Systems: An Adroit Quality Automation and Validation Partner - https://www.insightssuccess.in/infra-control-systems-adroit-quality-automation-validation-partner/
My views on Compliance and Compliance Training
https://www.youtube.com/watch?v=F3Z9JA0cRj8&t=3s
“Quality is an advantage. Quality is a privilege. Quality is not a cost.”
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.
+919825047998
+918320551508
[email protected]
Kalpeshkumar Vaghela
+919825047998
Kalpeshkumar Vaghela
Infra Control Systems
KVS Technologies
[email protected]
kvstechnologieskrv
Kalpeshkumar Vaghela
We provide services to Customers of India as well as Global clients. The company is providing solution to Pharmaceuticals, Power Plants, Refineries and Petrochemicals, Steel-Cement and Metal industries, R & D Centers, Tyre Industries, Textiles, Defence, Nuclear Power Plants, OEM machine Manufacturer...
