Quality & Compliance
Lean CSV – How to Reduce Waste and Increase Value
What is lean? Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this...
Quality & Compliance
Risk-Based Computer System Validation and Rational Testing
Risk based approaches to validation of computerized systems have been heavily promoted since the publication of GAMP 5 and ASTM E2500. Yet we continue to see examples of validation overkill in the...
Three Key Steps to Conducting a Strong Investigation
Unexpected events often happen in the everyday world. However, in the regulated world great efforts are made to minimize the severity and frequency of unexpected events. Yet, despite best efforts,...