Kailash Nale, General Manager of Quality Operations at Watson Pharma Private Limited, writes a letter of appreciation to KVS Technologies. The letter thanks KVS Technologies for satisfactorily completing software validations at Watson Pharma's Goa formulation plant site. KVS Technologies' resources are well-versed in software validations and 21 CFR Part 11 compliance. The validation documents produced by KVS Technologies meet GAMP5 guidelines and are high quality.
The document discusses the pharmaceutical industry in India and its growth potential. It notes that India has a large talent pool of scientists and engineers at a lower cost compared to Western nations. However, the industry faces challenges of inadequate infrastructure, regulatory hurdles, and a lack of R&D spending and innovation. If these challenges can be addressed, India is well-positioned to become a global leader in pharmaceuticals.
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
Kailash Nale, General Manager of Quality Operations at Watson Pharma Private Limited, writes a letter of appreciation to KVS Technologies. The letter thanks KVS Technologies for satisfactorily completing software validations at Watson Pharma's Goa formulation plant site. KVS Technologies' resources are well-versed in software validations and 21 CFR Part 11 compliance. The validation documents produced by KVS Technologies meet GAMP5 guidelines and are high quality.
The document discusses the pharmaceutical industry in India and its growth potential. It notes that India has a large talent pool of scientists and engineers at a lower cost compared to Western nations. However, the industry faces challenges of inadequate infrastructure, regulatory hurdles, and a lack of R&D spending and innovation. If these challenges can be addressed, India is well-positioned to become a global leader in pharmaceuticals.
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
1. The document provides specifications for various humidity, temperature, and environmental measurement instruments from Infra Control Systems including thermo-hygrometers, thermometers, anemometers, timers, and moisture meters.
2. Models range in size from pen-shaped units for field use to larger "super jumbo" devices with extra large digits.
3. Instruments measure parameters like humidity, temperature, air velocity, sound level, thickness, insulation resistance, grain moisture, and light intensity.
1. The document provides specifications for various humidity, temperature, and environmental measurement instruments from Infra Control Systems including thermo-hygrometers, thermometers, anemometers, timers, and moisture meters.
2. Models range in size from pen-shaped units for field use to larger "super jumbo" devices with extra large digits.
3. Instruments measure parameters such as humidity, temperature, air velocity, sound level, thickness, insulation resistance, grain moisture, and light intensity.
1. The document provides specifications for various humidity, temperature, and environmental measurement instruments from Infra Control Systems including thermo-hygrometers, thermometers, anemometers, timers, and moisture meters.
2. Models range in size from pen-shaped units for field use to larger "super jumbo" devices with extra large digits.
3. Instruments measure parameters like humidity, temperature, air velocity, sound level, thickness, insulation resistance, grain moisture, and light intensity.
1. The document provides specifications for various humidity, temperature, and environmental measurement instruments from Infra Control Systems including thermo-hygrometers, thermometers, anemometers, timers, and moisture meters.
2. Models range in size from pen-shaped units for field use to larger "super jumbo" devices with extra large digits.
3. Instruments measure parameters such as humidity, temperature, air velocity, sound level, thickness, insulation resistance, grain moisture, and light intensity.