Answer the challenges of CDS Data integrity - Sterling Pharma Solutions Ltd
Sterling Pharma Solutions Ltd
Data integrity continues to be a hot topic for the regulatory agencies in the pharmaceutical industry.
In 2012, Sterling Pharma Solutions, embarked on a mission to replace their existing chromatography data systems (CDS).
It was important to have one system for the entire company spanning both laboratories that could work with the existing instrumentation. Previously, there were two separate CDS, one for each laboratory, each with their own shortcomings on compliance and efficiency, each with their own specialist users and setup, leading to a lack of cohesion between the laboratories. The new CDS would have to be able to unite the laboratories and provide improved compliance, data integrity and efficiency to the whole business.
Using Sterling’s audit experiences and looking at current data integrity issues discover the features of Chromeleon that can ensure and demonstrate compliance.
Attend this Webinar to learn:
• Understanding audit trails: Why review, how to review and what to look for?
• Integration: Manual vs Automatic. Is manual acceptable? Control and monitoring.
• Data Completeness: Orphan data, what is it? Can review procedures demonstrate you are reporting complete data sets?
• Use of Chromeleon CDS queries and report templates: Demonstrate control and compliance.