COMPUTER SYSTEMS VALIDATION
Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in order to ensure product safety and effectiveness. In the United States, for example, the FDA requires pharmaceutical companies to perform CSV for systems that support the production of the following products:
- Pharmaceutical/
Biopharmaceutical - Biologicals
- Bio-Science
- Medical Devices
- Bio-Clinical
- Chemical and biotechnology
- Human cell and tissue products
- Infant Formulas
Our Services
COMPUTER SYSTEMS VALIDATION
Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world..
HEALTHCARE AND PHARMACEUTICALS
The healthcare and pharmaceutical industry in the United States has its primary resources tied up in the form of intangibles.
MEDICAL DEVICES
The medical device industry relies on several industries where the United States holds a competitive advantage, including microelectronics telecommunications..
REGULATORY AFFAIRS
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of..
QUALITY ASSURANCE
Quality Assurance (QA) is a wide concept and covers all aspects that could have an impact on the quality of prescribed pharmaceutical products..
INFORMATION TECHNOLOGY
We provide services under the Information Technology for services like Java, DevOps, .net, Sales Force, SAP, Oracle, AWS..
CLEANING VALIDATION
As a pharmaceutical professional, you are faced with the ongoing challenge of ensuring the quality, safety, and efficiency..