Automation
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
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
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
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