Success Stories

Business Case: Process Validation in the Pharmaceutical Industry
Introduction Process validation is essential for ensuring the quality and safety of pharmaceutical products, and it is governed by regulations such as cGMP, GMP for Medical Devices, and ISO 13485:2016. This practice is a cornerstone for upholding industry standards...
Business Case: Excel Spreadsheet Use in Pharma
Using Excel Spreadsheets in Pharma can be a powerful resource, but its flexibility and accessibility can also threaten data integrity and compliance in the world of pharmaceuticals.   Challenge The application of Excel spreadsheets within the pharmaceutical...
Business Case: How to De-Risk Decentralized Cell & Gene Therapies Models
Decentralized manufacturing of Cell & Gene Therapies (CGT) at the Point of Care (PoC) are very complex treatments involving multiple stakeholders, systems and areas. To identify, analyze and mitigate potential risks of decentralized vein-to-vein CAR-T...
Business Case: Validation of a Bayesian Multilevel Monitoring System (BMMS)
KVALITO recently supported its pharmaceutical client in implementing and validating their Bayesian Multilevel Monitoring System. The Bayesian Multilevel Monitoring system monitors the safety of clinical trials in Oncology Biometrics and Data Management, Global...