GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211. List of GxP Compliance Checklist People 1. Are all…
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 Internet of Things (IoT), from…
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 validation documents, change controls, previous…
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 to determine if they have…
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 a computer system meets regulatory…