COMPUTER SYSTEMS VALIDATION
Computer System Validation (CSV) is a formal, documented process mandated by regulatory authorities worldwide to ensure that computerized systems perform their intended functions consistently, accurately, and reliably.
These regulations are in place to safeguard the integrity and accuracy of data managed by computerized systems, ultimately ensuring the safety, quality, and efficacy of regulated products. In the United States, for instance, the Food and Drug Administration (FDA) requires pharmaceutical and life sciences companies to conduct CSV for systems involved in the development, manufacturing, and control of the following product categories:
- Pharmaceutical/
Biopharmaceutical - Biologicals Products
- Bio-Science
- Medical Devices
- Bio-Clinical Application
- Chemical and biotechnology Products
- Human cell and tissue products
- Infant Formulas
CSV is a critical component in demonstrating regulatory compliance and maintaining product integrity throughout the system lifecycle.
Our Services
COMPUTER SYSTEMS VALIDATION
Computer System Validation (CSV) is a formal, documented process mandated by regulatory authorities worldwide to ensure that…
HEALTHCARE AND PHARMACEUTICALS
The Healthcare and Pharmaceutical industries are among the most regulated and innovation-driven sectors in the global economy…
MEDICAL DEVICES
The Medical Device industry operates at the intersection of technology, innovation, and patient care. With growing regulatory scrutiny…
REGULATORY AFFAIRS
Regulatory Affairs is a critical function within the life sciences industry, ensuring that products—whether pharmaceuticals, biologics…
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..