Kalpeshkumar Vaghela

CEO [Vadodara, India]

No Image

  Experience

30 years

  Organization Served

  • GECO Prakla

Membership

  • PDA
  • PDA
  • PDA
  • VCCI
  • VCCI
  • VCCI
  • DILT
  • DILT
  • DILT
  • ISPE
  • ISPE
  • ISPE

  Overview

Recent Data Integrity Issues are pointing more towards the lack of proper training on how computer system affect the predicate rules and CFR 211 and CFR210. We started educating pharma as well as IT Company Team on this issue and more than 20 sessions already conducted at Various Leading IT and Pharma Companies. The cost of NON Compliance for
Dr Reddy’s
IPCA
Wockhardt
Zydus
Emcure
Lupin
Sun Pharma
Cadila Pharma
Natco
Mylan resulted in heavy cost of money to be spent

We train people on
21 CFR part 11 compliance
Annex 11
GAMP5
Why Validation
ALCOA Plus
Risk Assessment
CSV Deliverable
How to have full proof Data Integrity

to major Pharma Companies Like Lupin, Sun, Watson, Wockhardt, Cipla, Alembic and It Companies like Wipro, HCL, MphesiS. It pays to be with the leader as cost of non compliance or Data Integrity is extremely High. We also work in USA, Europe, Middle East and China. When we see lot of company getting 483 and warning letter. We feel real bad.
Infra Control Systems (ICS) & KVS Technologies (KVS) were created to help people get benefit of good Automation with quality product.We teach people Why and How of Compliance. The very basics employees learn they will do everything at their disposal to do quality work as it reflects their own existence.
We have been helping companies of India and Mother Earth on Software Validation, Data Integrity and Training on Compliance.
Good CSV can help you Reduce CAPA, Change Control, Batch Recall and give all people on earth a good Peace of mind including your shareholders. Data Integrity, Security, Patient safety and Product Quality is a key thing.
we are regarded as No.1 software validation company of India with presence in India and abroad. 80% of Top Pharma Company is client of Infra Control Systems or KVS Technologies. Good Care needed to be taken while selecting the Software validation consultant in checking their Facility, Company Management, Management Goals, Ranking Industry wise and Pharma Sector Wise, Experience of working with Top companies of the world, Vision and Team strength.
We have tie up with world renowned team like Premier Validation UK , FDASmart , Life Science Expertise - France, Atachi USA (MES) , Learn About GMP Online Platform from USA and many more..
We have proved our merits time and again. We are rated as 20 most Promising Pharma and Biotechnologies Solution provider company of India for the year 2015-16 and 2014-15. In Validation Category there is only one entry and that is we. We were also selected for Power of Idea Best Business Idea contest pan India.
Year 2015 CIO review Top 20 Pharma Solution provider
Please refer Page no 6, 16-17 and 34

http://www.cioreview.in/magazines/pharma-special-nov-2015/

Year 2014 CIO review Top 20 Pharma Solution provider

http://www.cioreview.in/magazines/Pharma-mazter/
Please go to page 18-19 and 22.

If you still want more evidence visit company website www.kvstech.com and www.infraics.in and you will see references from all great people. Call any good quality person and he will have only one name in mind as far as validation is concern and that is we. We train people and we do actual work so our training helps sharpening the saw.

Our Expertise
1) Computer Systems Validation for Manufacturing Area
2) Computer Systems Validation for Laboratory Area and Instruments
3) CSV Validation for all types of ERP – SAP Systems
4) CSV Validation for BMS Systems
5) CSV for Document management – Learning management Systems
6) CSV for EBMR and EBPR as well as MES Systems
7) CSV for Excel Validation
8) CSV for Clinical Research Software
9) Audit and GAP Analysis for 21 CFR Part 11 Compliance and Annex 11 Compliance
10) Fool proof System owner job validation like Data Integrity, Backup – restoration, Archival- retrieval – data Retention and Migration check.
11) Compliance Training on Why Validation ? , Role of FDA, 21 CFR part 11 Compliance, Annex- 11, GAMP5, Risk Assessment, CSV Deliverables, Data Integrity.
Point 11 is of ultimate importance on which many company do not focus. I bet that if all staff is given training on Data Integrity and Compliance the return to the company will be multifold.
We have successfully worked in USA, Europe, Ireland, Ice Land, China, South Africa, Middle East and now gearing up to serve the whole world in a big way. Best quality services at reasonable price and 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, 8758217198. Wirte to infraics@yahoo.com, kvstech7@yahoo.co.in
You can trust us for USFDA, MHRA, TGA, ANVISA, MCC and other critical Audit.
One look at our website references will give you clear idea about our capability. Please get in touch to know more about our services. We can provide most of the services you need. We are famous for successful execution of the same.

Select Client List include
Mylan Nasik-Pithampur- Hyderabad
Piramal Health care Pithampur-Baddi-Ahmedabad-Mumbai
Sun Pharma Halol-Karakhadi-Daman
Alembic Halol-Kharakhadi
Wockhardt Daman-Ankleshwar-Aurangabad-Baddi-USA
Dr Reddy’s Lab Hyderabad-Vaizag-Baddi
Ranbaxy Baddi-Pontasahib-Dewas-Mohali
Glenmark Goa- Ankleshwar- Pithampur
Fresenius Kabi – baddi
Abbott Baddi
Watson Goa- Ambernath- Mumbai- Ice land
And many more……

International client list Includes Giants like
Emerson process Management- China BMS/EMS and Training
Horiba –yuovn Scintific - Japan –France Raman Spectroscopy Lab Instrument
Muscat Pharmacy – Biggest Retail chain of Middle East for Pharma- food- medical devices.
Morton Grooves - Chicago Il USA
Watson Iceland
Premier Validation U.K


With 10 year of work experience on high level CSV Validation in India and Abroad has made us to start special Data integrity Audit of your firm. We check the CSV of sample selected and procedures, Training program plus review , Change and Capa procedures. People are gaining a lot. Cost of non compliance is extremely high.

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  Experience

Sr Observer, GECO Prakla , Houston, USA

03-Mar-1987 to 21-Apr-1993

Job Type : Full Time

Looking after Computer Systems, Instrumentation and Electronics Systems. Leading the Team

Clients Worked For
Shell, Axxon, Mobil, and All Companies of the world


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Kalpeshkumar Vaghela

CEO [Vadodara, India]

Total expertience : 30 years

Overview

Recent Data Integrity Issues are pointing more towards the lack of proper training on how computer system affect the predicate rules and CFR 211 and CFR210. We started educating pharma as well as IT Company Team on this issue and more than 20 sessions already conducted at Various Leading IT and Pharma Companies. The cost of NON Compliance for
Dr Reddy’s
IPCA
Wockhardt
Zydus
Emcure
Lupin
Sun Pharma
Cadila Pharma
Natco
Mylan resulted in heavy cost of money to be spent

We train people on
21 CFR part 11 compliance
Annex 11
GAMP5
Why Validation
ALCOA Plus
Risk Assessment
CSV Deliverable
How to have full proof Data Integrity

to major Pharma Companies Like Lupin, Sun, Watson, Wockhardt, Cipla, Alembic and It Companies like Wipro, HCL, MphesiS. It pays to be with the leader as cost of non compliance or Data Integrity is extremely High. We also work in USA, Europe, Middle East and China. When we see lot of company getting 483 and warning letter. We feel real bad.
Infra Control Systems (ICS) & KVS Technologies (KVS) were created to help people get benefit of good Automation with quality product.We teach people Why and How of Compliance. The very basics employees learn they will do everything at their disposal to do quality work as it reflects their own existence.
We have been helping companies of India and Mother Earth on Software Validation, Data Integrity and Training on Compliance.
Good CSV can help you Reduce CAPA, Change Control, Batch Recall and give all people on earth a good Peace of mind including your shareholders. Data Integrity, Security, Patient safety and Product Quality is a key thing.
we are regarded as No.1 software validation company of India with presence in India and abroad. 80% of Top Pharma Company is client of Infra Control Systems or KVS Technologies. Good Care needed to be taken while selecting the Software validation consultant in checking their Facility, Company Management, Management Goals, Ranking Industry wise and Pharma Sector Wise, Experience of working with Top companies of the world, Vision and Team strength.
We have tie up with world renowned team like Premier Validation UK , FDASmart , Life Science Expertise - France, Atachi USA (MES) , Learn About GMP Online Platform from USA and many more..
We have proved our merits time and again. We are rated as 20 most Promising Pharma and Biotechnologies Solution provider company of India for the year 2015-16 and 2014-15. In Validation Category there is only one entry and that is we. We were also selected for Power of Idea Best Business Idea contest pan India.
Year 2015 CIO review Top 20 Pharma Solution provider
Please refer Page no 6, 16-17 and 34

http://www.cioreview.in/magazines/pharma-special-nov-2015/

Year 2014 CIO review Top 20 Pharma Solution provider

http://www.cioreview.in/magazines/Pharma-mazter/
Please go to page 18-19 and 22.

If you still want more evidence visit company website www.kvstech.com and www.infraics.in and you will see references from all great people. Call any good quality person and he will have only one name in mind as far as validation is concern and that is we. We train people and we do actual work so our training helps sharpening the saw.

Our Expertise
1) Computer Systems Validation for Manufacturing Area
2) Computer Systems Validation for Laboratory Area and Instruments
3) CSV Validation for all types of ERP – SAP Systems
4) CSV Validation for BMS Systems
5) CSV for Document management – Learning management Systems
6) CSV for EBMR and EBPR as well as MES Systems
7) CSV for Excel Validation
8) CSV for Clinical Research Software
9) Audit and GAP Analysis for 21 CFR Part 11 Compliance and Annex 11 Compliance
10) Fool proof System owner job validation like Data Integrity, Backup – restoration, Archival- retrieval – data Retention and Migration check.
11) Compliance Training on Why Validation ? , Role of FDA, 21 CFR part 11 Compliance, Annex- 11, GAMP5, Risk Assessment, CSV Deliverables, Data Integrity.
Point 11 is of ultimate importance on which many company do not focus. I bet that if all staff is given training on Data Integrity and Compliance the return to the company will be multifold.
We have successfully worked in USA, Europe, Ireland, Ice Land, China, South Africa, Middle East and now gearing up to serve the whole world in a big way. Best quality services at reasonable price and 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, 8758217198. Wirte to infraics@yahoo.com, kvstech7@yahoo.co.in
You can trust us for USFDA, MHRA, TGA, ANVISA, MCC and other critical Audit.
One look at our website references will give you clear idea about our capability. Please get in touch to know more about our services. We can provide most of the services you need. We are famous for successful execution of the same.

Select Client List include
Mylan Nasik-Pithampur- Hyderabad
Piramal Health care Pithampur-Baddi-Ahmedabad-Mumbai
Sun Pharma Halol-Karakhadi-Daman
Alembic Halol-Kharakhadi
Wockhardt Daman-Ankleshwar-Aurangabad-Baddi-USA
Dr Reddy’s Lab Hyderabad-Vaizag-Baddi
Ranbaxy Baddi-Pontasahib-Dewas-Mohali
Glenmark Goa- Ankleshwar- Pithampur
Fresenius Kabi – baddi
Abbott Baddi
Watson Goa- Ambernath- Mumbai- Ice land
And many more……

International client list Includes Giants like
Emerson process Management- China BMS/EMS and Training
Horiba –yuovn Scintific - Japan –France Raman Spectroscopy Lab Instrument
Muscat Pharmacy – Biggest Retail chain of Middle East for Pharma- food- medical devices.
Morton Grooves - Chicago Il USA
Watson Iceland
Premier Validation U.K


With 10 year of work experience on high level CSV Validation in India and Abroad has made us to start special Data integrity Audit of your firm. We check the CSV of sample selected and procedures, Training program plus review , Change and Capa procedures. People are gaining a lot. Cost of non compliance is extremely high.


Organization Served

  • GECO Prakla

Membership

  • PDA
  • PDA
  • PDA
  • VCCI
  • VCCI
  • VCCI
  • DILT
  • DILT
  • DILT
  • ISPE
  • ISPE
  • ISPE

Experience

Sr Observer, GECO Prakla , Houston, USA

03-Mar-1987 to 21-Apr-1993

Job Type : Full Time

Looking after Computer Systems, Instrumentation and Electronics Systems. Leading the Team


Clients Worked For
Shell, Axxon, Mobil, and All Companies of the world




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