However, with the evolving regulatory guidelines and the assistance of Thermo Fisher Scientific, we have been able to gain an in-depth understanding of the Chromeleon software and the controls we need to have in place to not only ensure compliance, but also carry out routine self-inspections which help us to gather evidence to demonstrate that we are in complete control of our systems and processes. Over the nine years Sterling has had the Thermo Scientific™ Chromeleon™ 7 CDS, we have developed a comprehensive set of procedures that make it easier for us to maintain and demonstrate control of our system.Īs is often the way, when Chromeleon CDS was first installed none of our current control measures were in place.
Keeping control of a Chromatography Data System (CDS) is a never-ending task, but it is a task that must be done in order to adhere to GxP and data integrity guidelines and to keep you audit ready. By Tegan Rawlinson, Chromeleon and Data Compliance Administrator, Sterling Pharma Solutions
