CSV

Computer System Validation in Pharmaceutical Industry

Computer System Validation in Pharmaceutical Industry

CSV is the process of testing/validating/qualifying regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. The validation process begins with planning, system requirements definition, testing and verification activities, ... Read More
GXP Compliance | The Future of Validation

GXP Compliance | The Future of Validation

As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the ... Read More
Executing Efficient and Effective CSV Audits

Executing Efficient and Effective CSV Audits

Once planning is complete, it’s time to execute the actual CSV audit. Here are some tips for conducting rigorous, value-adding CSV audits: Interview StakeholdersDiscuss in-depth with stakeholders like system owners, quality managers, and end users. This provides insights into how systems are used and any issues. Examine DocumentationThoroughly review all ... Read More
Computerized System Validation (CSV) Audits

Computerized System Validation (CSV) Audits

Computerised system validation (CSV) is critical in regulated industries like pharmaceuticals, medical devices, and biotech. It ensures that computerised systems are compliant with guidelines and capable of consistently producing high-quality products and data. A key component of the CSV process is CSV auditing. CSV audits examine and evaluate computerised systems ... Read More
Regulatory Guidelines for CSV

Regulatory Guidelines for CSV

Embarking on the path to a successful Computer System Validation (CSV) roadmap begins with a solid understanding of the applicable regulatory requirements within your industry and region. Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial ... Read More
Walking Through the 21 CFR Part 11

Walking Through the 21 CFR Part 11

FDA

If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the United States Food and Drug Administration’s (FDA’s) 21 Part 11 Regulation. We begin by decoding 21 CFR Part 11 itself: The CFR is organized like this: Title > Chapter > ... Read More
Difference Between CSV and CSA

Difference Between CSV and CSA

Definition Computer system validation (CSV) is the process of ensuring that a computer system meets its intended use and performs as expected, while computer system/software assurance (CSA) is the process of ensuring that a computer system is secure, reliable, and available. Purpose The purpose of CSV is to ensure that ... Read More