Swaroop Tech Services Pvt. Ltd formerly known as Swaroop Tech Consultancy was founded in the year 1997 in Delhi, India. It launched its very first software product (PRO-INVEST) in this year. The company started its operations by training scientists and engineers in the area of Process development with built in quality, when the quality initiatives like TQM, TPM, and ISO-9000/1400 etc were at center stage in many organizations.
Building quality in to the process / products has been envisaged through Quality Engineering practices and training was offered by many an Institutions. Even the use of computers has been quite prevalent for many applications. But after the training Scientists and Engineers were finding it difficult to put in to practice the methods learnt in the training programs. Recognizing these challenges faced by the scientists and engineers, the company undertook an initiative in providing software solutions in materials and life sciences areas on the use of modeling in real industrial research applications and launched its first software product PRO-INVEST in the year 1997. PRO-INVEST was a user friendly menu driven software designed for scientists and engineers who are novice in software and computers and should be able to use it after the training, in their day to day job. The main techniques introduced in the software were Factorial Design of Experiments, Fractional factorial Design of Experiments, Statistical analysis, process model building and simulation for optimization of the process.
As Process Measurement gained lot of importance in ISO and the importance of Robust Process development was realized even in Six Sigma methodology, the company launched another product CADROB in the year 2000 incorporating these new features namely Process Measurement and Robust Process Development into the product. To make it more versatile to run on any platform the software was further upgraded and revised as SIGMATECH with some more additional features in the year 2002.
Since its inception in 1997, the company offered its software along with training and consultancy of projects and has successfully marketed to Commercial Organizations, Academicians, and Professional Institutions in India and Asia-Pacific regions. It has also helped under-grad, graduate and doctorate students in completion of their projects and training with the help of these software packages designed by Swaroop Tech Services Pvt. Ltd. Successful completion of the Research Projects also saw several papers being published in various International and National Journals.
In 2006, Swaroop Tech Services Pct. Ltd launched its new product SIGMATECH 3.1 incorporating most up to date features in the areas of quality standards as issued by ICH (International Council for Harmonization ) such as Q8 guidelines in on pharmaceutical development, Q9 on quality risk management and Q10 for the use of Quality Management( comprising of basically Regional GMP and ISO Quality System) with concept of Quality by Design (QbD) to build the quality in to the process and products right at the stage of process development. In June 2006, FDA issued the same concepts in its Guidance for Regulated Industry like Pharmaceutical, Biological, Medical devices etc. SIGMATECH 3.1 also has functionality and features such as Statistical analysis, Design Space, Simulation in Robust Methods, 21 CFR Part 11 Compliance etc.
Mr. Bhadrayya Kalva is the President and founder of Swaroop Tech Services Pvt.Ltd, a professional services company that provides consulting and training in robust process design and product development for pharmaceutical, chemical and other organizations, including professional and educational institutions. He has worked over 40 years in pharmaceutical industry in various capacities such as Chief engineer, General Manager etc. for a large pharmaceutical company IDPL( Indian Drugs & Pharamceuticals Ltd) . He has harnessed his rich experience in developing a software for robust/ process design and product development namely SigmaTech.
- General Manager, Indian Drugs & Pharmaceutical Ltd (IDPL),
- Board of Director, Rajasthan Drugs & Pharmaceuticals Ltd.,
- Chief Engineer, Indian Drugs & Pharmaceutical Ltd (IDPL),
- Visiting Professor, BITS Pilani, INDIA,
- Visiting Professor, Management Development Institute, Gurgaon, INDIA.
- Post Graduate Diploma in TQM and ISO-9000/ ISO-14000.
- Graduate in Industrial Engineering, Operations Research and Statistics.
- Graduate in Chemical Engineering
- Certification program in Six Sigma process development
professional member ship
- Life Member, Quality Circle Forum of India.
- Life Member, Indian Institute of Chemical Engineers.
- Life Member, Indian Institute of Plant Engineers.
- Life Member, Indo French Technology Association.
- Fellow Ship Corporate Member, Indian Institution of Industrial Engineering.
Areas of Expertise
Quality by Design (QbD) ~ Design of Experiments (DOE) ~ Process/product development to meet ICH Q8, ICH Q9 and ICH Q11 as recommended by FDA ~ Placket Burmann methods, Taguchi methods and Response Surface Methods ~ Robust Process Design ~ with the help of Sigma Tech a software for process design .
Use of Quality Risk analysis to find out the CQAs ( Critical Quaity Attributes ) from QTPP ( Quality Target Product Profile ), Risk assessment of CQAs vs UO/UP ( Unit operations/ Unit Processes) and identifying high risk operations, assessing the relation ship between API attributes and CQAs , identifying control strategy, Establishing Design space, CPPS to obtain CQAs and Scale up co-relations approach etc.