Risk management for GxP Technology Implementation

Risk management for GxP Technology We rely on technology in most areas of our life. All of the tools we use to get through our day are now built, operated, and managed via technology. The understanding that we have reached with technology is that it will do what its supposed to do,¬†with minimal interference or […]

Review of eSource for Clinical Trials

Review of eSource for Clinical Trials Overview – source data Electronic data in support of new drug applications have been the standard for submittal to regulatory authorities – ever since computers were found to be reliable and their prevalence made them readily available. For much of that time, however, the source documents on which the […]

Computer System Validation in the Life Sciences: The Basics

Introduction Computer system validation in the Life Sciences is a process to ensure data integrity, particularly patient-related data, that is accumulated and stored in a computer system. One aspect of data integrity is ensuring that data is collected accurately – that is, the value of a data point is transferred to the system in a […]